The purpose of this study is to investigate the safety and tolerability of 3 multiple and escalating dose regimens of CG400549 administered orally in healthy volunteers.
This is a Phase 1, 3 cohorts study consisting of a randomised, double-blind, and placebo-controlled design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
multiple oral doses of 640 mg CG400549 (n=6) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state
multiple oral doses of 320 mg CG400549 (n=6) QD for 5 days in the fed state
multiple oral doses of 640 mg CG400549 (n=6) QD for 5 days in the fed state
PRA International clinical center
Zuidlaren, Netherlands
Number of participants with adverse events
Time frame: From Time the ICF is signed until Follow up Visit (15 days after study drug administration)
Pharmacokinetics-tmax(h), Cmax (ng/mL), Auc (0-24), T1/2(h)
To determine the pharmacokinetics of CG400549 following oral administration of multiple ascending doses of CG400549 in healthy male subjects.
Time frame: Day1 and Day5
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multiple oral doses of 960 mg CG400549 (n=6) QD for 5 days in the fed state
multiple oral doses of 640 mg placebo (n=2) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state
multiple oral doses of 320 mg placebo (n=2) QD for 5 days in the fed state
multiple oral doses of 960 mg placebo (n=2) QD for 5 days in the fed state
multiple oral doses of 640 mg placebo (n=2) QD for 5 days in the fed state