A 2-part, Randomized, Double-blind, Placebo-controlled, Sequential Group, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG2737 in Healthy Male Subjects
Abstract
This study is a first-in-human (FIH), Phase I, single center, randomized, double-blind, placebo-controlled, sequential group study in healthy male subjects to assess the safety, tolerability and PK of single ascending oral doses of GLPG2737 and multiple ascending oral doses of GLPG2737 administered for 14 days.
Conditions: Healthy.
Primary outcome: Change versus placebo in the proportion of subjects with adverse events.
Enrollment: 79 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 79 participants or records.
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