Table of contents
- Trial overview
- Study design and who joined
- What was measured
- Conditions and target population
- What the trial can tell researchers
Trial overview
This article summarizes one clinical trial of 2-(5-BROMOPYRIDIN-3-YL)SULFANYL-6-(HYDROXYMETHYL)-4-[4-(3,4,5-TRIFLUOROPHENYL)TRIAZOL-1-YL]OXANE-3,5-DIOL, also listed in the source as GB1211.[1] The study was an open-label, randomized, three-period crossover trial in healthy volunteers.[1] It was a Phase 1 study and is marked as completed.[1]
Study design and who joined
The trial compared a capsule taken under fasting conditions with a tablet taken under fasting and fed conditions.[1] In a crossover study, the same participants can receive different study forms at different times, which helps researchers compare them more fairly.[1] The enrollment was 12 participants, and the brief summary says they were healthy volunteers.[1]
The conditions field in the source lists non-small cell lung cancer, advanced liver fibrosis, and cirrhosis.[1] However, the study summary specifically says the trial was done in healthy volunteers, so the main research population described in the trial details is healthy people rather than patients with those diseases.[1]
What was measured
The main outcome was pharmacokinetic data, which means how the body absorbs, moves, and removes the substance.[1] The study measured plasma values such as AUC0-last, AUC0-inf, Cmax, Tmax, CL/F, and Vz/F.[1] These measures help show total exposure, the highest blood level, the time to peak level, and how the substance is cleared from the body.[1]
The trial also measured urine pharmacokinetic values, including Ae and Fe.[1] These urine measures help researchers understand how much of the substance leaves the body in urine and how much is excreted over time.[1]
Conditions and target population
The source data list disease areas in the conditions field, including non-small cell lung cancer, advanced liver fibrosis, and cirrhosis.[1] Even so, the actual study description says the trial was carried out in healthy volunteers, which means the target population in the trial conduct was not a patient group with those listed conditions.[1]
This type of early trial is often used to compare different formulations, such as a tablet and a capsule, and to see whether food changes the way the body handles the study product.[1] In this study, the brief summary says the goal was to compare the tablet with the capsule under fasting conditions and to assess the effect of food on the tablet form.[1]
What the trial can tell researchers
Because this was a small Phase 1 study, its main value was to give early information about how 2-(5-BROMOPYRIDIN-3-YL)SULFANYL-6-(HYDROXYMETHYL)-4-[4-(3,4,5-TRIFLUOROPHENYL)TRIAZOL-1-YL]OXANE-3,5-DIOL behaves in the body.[1] The results can help researchers decide whether one oral form gives similar exposure to another form and whether food changes that exposure.[1] The trial does not provide disease outcome results, because the main focus was pharmacokinetics in healthy volunteers.[1]
