NCT01085578

CG400549 Single Ascending Dose Study

Evaluation of Safety,Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: CrystalGenomics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy Volunteers

Detailed description

This was a Phase 1, 2-part study consisting of a randomized, double-blind, placebo-controlled,single ascending dose (SAD) part (in 2 alternating panels) and a 1-sequence food effect (FE) part. In the SAD part, 2 cohorts of 6 healthy male subjects each received a single oral dose of CG400549 or placebo in 3 periods, randomized such that each subject received active treatment twice and placebo once (in each period, 4 subjects received active drug and 2 received placebo). In the FE part, 1 cohort of 6 healthy male subjects received a single oral dose of CG400549 in the fasted state in Period 1 and a single oral dose of CG400549 in the fed state in Period 2.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CG400549/placebo	Period 1: a single oral dose of 80 mg CG400549 or placebo on Day 1 Period 2: a single oral dose of 320 mg CG400549 or placebo on Day 1 Period 3: a single oral dose of 1280 mg CG400549 or placebo on Day 1
DRUG	CG400549/placebo	Period 1: a single oral dose of 160 mg CG400549 or placebo on Day 1 Period 2: a single oral dose of 640 mg CG400549 or placebo on Day 1 Period 3: a single oral dose of 1920 mg CG400549 or placebo on Day 1
DRUG	CG400549	Period 1: a single oral dose of 640 mg CG400549 on Day 1 in the fasted state Period 2: a single oral dose of 640 mg CG400549 on Day 1 in the fed state

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2010-03-12
• Last updated: 2022-05-20

Locations

1 site across 1 country: Netherlands