Multiple Ascending Doses Study of CG400549

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo 640mg; Drug: CG400549 640mg; Drug: CG400549 320 mg; Drug: CG400549 640 mg; Drug: CG400549 960 mg; Drug: Placebo 320mg; Drug: placebo 960 mg

• Registration Number: NCT01848470
• Lead Sponsor: CrystalGenomics, Inc.

Brief Summary

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.

Detailed Description

This is a Phase 1, 3 cohorts study consisting of a randomised, double-blind, and placebo-controlled design.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2013-02-13
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-03
• Last Update Submitted: 2013-05-03
• Study First Posted: 2013-05-07
• Last Update Posted: 2013-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

• Age:18-55 years, inclusive
• Body Mass Index :19-30 kg/m2, inclusive
• Sex:male
• Other criteria:healthy; non-smoking or smoking ≤ 10 cigarettes/day

Exclusion Criteria

• Evidence of clinically relevant pathology
• History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month of study
• Presence or history of esophageal or gastroduodenal ulceration within 1 month before screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P1 Placebo	Placebo 640mg	Placebo 640mg BID on Day 1-5 and QD on Day 6 in the fed-state
E1. CG400549 640mg	CG400549 640mg	CG400549 640mg BID on Day 1-5 and QD on Day 6 in the fed-state
E2: CG400549 320mg	CG400549 320 mg	CG400549 320mg QD on Day 1-5 in the fed-state.
E3: CG400549 640mg	CG400549 640 mg	CG400549 640mg QD on Day 1-5 in the fed-state.
E4: CG400549 960mg	CG400549 960 mg	CG400549 960mg QD on Day 1-5 in the fed-state.
P2: Placebo 320mg	Placebo 320mg	Placebo 320mg QD on Day 1-5 in the fed-state
P3 Placebo 640mg	placebo 960 mg	Placebo 640mg QD on Day 1-5 in the fed-state.
P4: Placebo 960mg	Placebo 640mg	Placebo 960mg QD on Day 1-5 in the fed-state.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	From Time the ICF is signed until Follow up Visit (15 days after study drug administration)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics-tmax(h), Cmax (ng/mL), Auc (0-24), T1/2(h)	Day1 and Day5	To determine the pharmacokinetics of CG400549 following oral administration of multiple ascending doses of CG400549 in healthy male subjects.

Trial Locations

Locations (1)

PRA International clinical center; 🇳🇱 Zuidlaren, Netherlands