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Pharmacokinetics, Pharmacodynamics and Safety of Inhaled and Intravenous d,l‑lysine acetylsalicylate in Healthy Adults with Migraine

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What is this study about?

The study focuses on migraine, a condition characterized by intense, throbbing head pain often accompanied by nausea and sensitivity to light. The medication being examined is LASAG, which contains the active ingredient D,L‑lysine acetylsalicylate combined with glycine. In this trial the drug is given in two ways: by breathing in a mist using a nebuliser (inhalation) and by a short injection into a vein (intravenous), allowing a direct comparison of the two delivery methods.

The purpose of the study is to determine how much of the drug reaches the bloodstream and how it works in the body after a single dose. Researchers will measure the drug’s pharmacokinetics (how the body absorbs, distributes, breaks down, and eliminates the medicine) and its pharmacodynamics (the effects the medicine has on the body). Healthy adult volunteers will receive one dose of each form under controlled, fasting conditions, with a short wash‑out period between administrations.

After each dose, participants will have blood samples taken to check drug levels, and simple safety checks such as blood pressure, heart rate, and heart rhythm will be performed. Any side effects or discomfort will be recorded, and basic lung function will be assessed to ensure the inhaled form is well tolerated. The study is open‑label, meaning that both the participants and the researchers know which form of the medication is being used.

1 baseline assessments

after joining the study, basic health measurements are taken, including vital signs, blood pressure, pulse, lung function, and a short laboratory blood test.

these measurements create a reference point for later comparison and ensure that the participant meets the health criteria for the trial.

2 fasting before each dose

the participant must not eat or drink anything except water for at least eight hours before any medication is given.

fasting helps to keep the drug absorption consistent for all dosing periods.

3 first inhaled dose (dose level 1)

a single dose of inhaled LASAG (d,l-lysine acetylsalicylate) is delivered using a nebuliser solution.

the amount administered is 750 mg, given once through the inhalation device.

after the dose, the participant remains seated and is monitored for safety and for blood sampling to measure drug levels.

4 observation period after first inhalation

blood samples are taken at several time points to assess how the drug is processed in the body.

vital signs and lung function are checked regularly during this period.

any side effects are recorded.

5 washout period

a break of several days is observed to allow the drug to leave the body completely before the next dose.

no study medication is taken during this time.

6 second inhaled dose (dose level 2)

a single dose of inhaled LASAG at a higher dose level is given using the same nebuliser solution.

the exact amount follows the study protocol for the second dose level and is administered once.

the same monitoring and blood‑sampling schedule as after the first dose is followed.

7 observation period after second inhalation

the participant continues to be observed for safety, vital signs, lung function, and drug concentration in the blood.

any adverse events are documented.

8 washout period

another break of several days is observed before the next dosing session.

no study medication is taken during this interval.

9 third inhaled dose (dose level 3)

a single dose of inhaled LASAG at the highest dose level is administered via the nebuliser solution.

the dose follows the study protocol for the third level and is given once.

post‑dose monitoring and blood sampling are performed as in the previous inhalation periods.

10 observation period after third inhalation

the participant is observed for safety, vital signs, lung function, and drug levels in the blood.

all side effects are recorded.

11 intravenous dose (comparator)

a single dose of intravenous LASAG (aspirin® i.v.) is given as a 500 mg solution for infusion.

the medication is delivered through a vein over a short infusion period, as defined by the study protocol.

after the infusion, the participant remains under observation for safety and blood sampling.

12 observation period after intravenous infusion

blood samples are taken at scheduled times to compare drug exposure with the inhaled doses.

vital signs, heart rate, and any adverse reactions are monitored continuously.

findings are recorded for later analysis.

13 part b – higher concentration inhalation

the participant receives a single dose of a higher‑concentration inhaled LASAG solution.

the dose is administered once using the nebuliser device, following the specific amount defined for part b of the study.

post‑dose monitoring, blood sampling, and safety checks are performed as in earlier inhalation periods.

14 final safety assessments and study completion

after the last observation period, a final set of vital‑sign measurements, lung‑function tests, and laboratory blood tests are performed.

all recorded adverse events are reviewed, and the participant is informed that the study procedures are finished.

Who Can Join the Study?

  • Be between 18 and 55 years old when you sign the consent form.
  • Give written informed consent before any study procedures begin.
  • Show that you can use the inhaler correctly after training at the screening visit.
  • Weigh at least 50 kilograms (about 110 pounds) at screening.
  • Have a body mass index (BMI) between 20.0 and 29.9, which is a measure of body size based on height and weight.
  • Be either male or female; both sexes are allowed.
  • If you are male, you must agree not to donate sperm and must use a highly effective contraceptive method (failure rate less than 1% per year) and a barrier method (such as a condom) when having sex with a partner who could become pregnant, or use a condom if the partner is pregnant or breastfeeding.
  • If you are female, you must not be pregnant or breastfeeding. You are eligible if you cannot become pregnant (because you are surgically sterile or postmenopausal) or, if you could become pregnant, you must use a highly effective contraceptive method starting at least 90 days before the first dose and continue until 90 days after the last dose, plus a barrier method from screening onward.
  • You must be in overall good health, as shown by a medical check that includes your medical history, a physical exam, vital signs, an ECG (a test that records the heart’s electrical activity), and laboratory tests.
  • Your lung function test called forced expiratory volume in 1 second (FEV1) must be greater than 80% of the value predicted for your age, sex, and height.
  • You must be a non‑smoker for at least 30 days before screening and must not have used any nicotine products (such as patches, gum, or e‑cigarettes) during that time.

Who Cannot Join the Study?

  • You have a history of serious illnesses (such as heart, lung, liver, kidney, digestive, hormone, blood, immune, metabolic, urinary, nervous system, skin, muscle, mental health problems, or cancer) that could change how the drug works or make it unsafe. (metabolism = how the body processes a drug; elimination = how the body removes a drug.)
  • You easily faint or have fainted before, especially after a needle stick. (Vasovagal reaction = fainting caused by a nerve response.)
  • You have had COVID‑19 symptoms or a positive COVID‑19 test in the past two weeks.
  • Your recent physical exam, heart test (ECG), breathing test, or lab tests show significant abnormalities that the doctor believes would keep you from joining.
  • Your blood pressure, heart rate, or body temperature is outside normal ranges when lying down. (Systolic/diastolic blood pressure = top/bottom numbers; pulse = heart beats per minute; temperature = body heat.)
  • Your heart’s electrical test (ECG) shows abnormal timing measurements.
  • Your platelet count (blood cells that help clot) is low. (Platelets = cells that stop bleeding.)
  • Blood tests show your liver or kidney function is higher than normal. (ALT/AST = liver enzymes; bilirubin = waste product from the liver; creatinine = kidney function test.)
  • Your thyroid hormone levels are abnormal. (Thyroid = gland that controls metabolism; TSH, T3, T4 = thyroid hormones.)
  • You test positive for hepatitis B, hepatitis C, or HIV infections.
  • You test positive for COVID‑19 (SARS‑CoV‑2).
  • You have significant allergies, including to foods, seasonal triggers, or medicines.
  • Your test shows recent use of alcohol, illegal drugs, or nicotine (detected as cotinine).
  • You are pregnant.
  • You are taking any other medicines, supplements, or herbal products within the past two weeks (or longer based on how long those substances stay in your body). (Concomitant medication = other medicines you are using.)
    • <liYou have taken an experimental drug or participated in another clinical trial recently (within 30 days or the appropriate time based on the drug’s stay in the body).
  • You have already taken part in this specific study before.
  • You regularly drink more than moderate amounts of alcohol (more than 14 drinks per week for men or 7 drinks per week for women). (Unit = about 12 g of alcohol, roughly one small glass of wine or 0.3 L of beer.)
    • <liYou have abused drugs or alcohol in the past six months.
  • You drink a lot of caffeine (more than five cups of coffee per day) or cannot stop caffeine for two days before the study. (Xanthine = component of caffeine.)
  • You have taken resveratrol supplements or substances that affect liver enzymes within the past two weeks.
  • You have eaten poppy seeds within the last three days.
  • You have had major stomach, intestine, or lung surgery that could affect how the drug is absorbed. (Gastrointestinal = stomach and intestines.)
  • You follow a special diet (vegetarian, vegan, gluten‑free, etc.) or cannot eat the meals provided for the study.
    • <liYou have lost a large amount of blood, donated more than about a pint (450 mL), or received a blood transfusion in the past month. <liYou performed intense exercise within three days before the study. <liYou work for the company running the study or its research partners. <liYou are unable to give legal consent because of mental or legal reasons, or you are currently incarcerated. <liYou cannot understand or reliably communicate with the study staff, or you are unlikely to follow the study instructions. <liYou cannot fully understand what the study involves, including its possible risks and side effects. <liAny other health or personal issue that the doctor thinks would affect the study. <liYou are allergic to aspirin (acetylsalicylic acid), lysine, or glycine. <liYou have conditions that make the study drug unsafe, such as asthma, allergy to aspirin‑like drugs (salicylates) or other non‑steroidal anti‑inflammatory drugs (NSAIDs), stomach ulcers, bleeding problems, kidney or liver disease, or gout (high uric acid). <liYou have a known deficiency of glucose‑6‑phosphate dehydrogenase (G6PD), a genetic condition affecting red blood cells. <liYou have a tendency to bleed easily, such as frequent nosebleeds or bleeding hemorrhoids. <liYou have a recent infection of the airway (like a cold, throat infection, or hoarseness) within the past two weeks. <liYou have any other serious infection or fever within the past two weeks.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Nkaqdwc Gcsw Gauting Germany
Niwqtqr Gofh Neu-Ulm Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
15.05.2023

Trial locations

Investigated Drugs:

D,L-LYSINE ACETYLSALICYLATE (inhalation) is a liquid that is placed in a nebuliser, which turns the medicine into a fine mist that can be breathed in. In this trial participants inhale the mist, allowing the drug to reach the lungs directly. The study is looking at how much of the medicine gets into the bloodstream after inhalation, how it works in the body, and whether it is safe when given this way. This inhaled form is the main test product and is being compared with other dose levels and with an intravenous version of the same drug.

Aspirin® i.v. (intravenous infusion) is a sterile solution that is injected into a vein, delivering the medication straight into the bloodstream. In the study it is used as a comparator, meaning it serves as a reference to see how the inhaled version behaves. By giving the drug intravenously, researchers can measure how the body processes it when it bypasses the lungs, and they can compare the amount of drug in the blood and any effects with those seen after inhalation. This helps determine whether the inhaled form provides similar or different exposure and safety profiles.

Investigated Diseases:

Migraine – Migraine is a neurological disorder that causes recurring moderate to severe headaches, often affecting one side of the head. The pain is typically throbbing and can last from a few hours to several days. It is commonly accompanied by nausea, sensitivity to light or sound, and visual changes known as aura. Attacks may start with warning signs such as mood shifts or neck stiffness. The pattern of episodes can vary, with some individuals experiencing occasional attacks while others have them more frequently.

Trial ID:
2022-503037-63-00
Protocol code:
ASPI-AAP-006-01
Trial Phase:
Human Pharmacology (Phase I) – Other

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