Multiple Ascending Doses Study of CG400549

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CG400549 640mg; Drug: CG400549 320 mg; Drug: CG400549 640 mg; Drug: CG400549 960 mg; Drug: Placebo 640mg; Drug: Placebo 640mg; Drug: Placebo 320mg; Drug: placebo 960 mg

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Zuidlaren, Netherlands
    • PRA International clinical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E1. CG400549 640mg; CG400549 640mg BID on Day 1-5 and QD on Day 6 in the fed-state	Drug: CG400549 640mg; 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
Experimental: E2: CG400549 320mg; CG400549 320mg QD on Day 1-5 in the fed-state.	Drug: CG400549 320 mg; multiple oral doses of 320 mg CG400549 (n=6) QD for 5 days in the fed state
Experimental: E3: CG400549 640mg; CG400549 640mg QD on Day 1-5 in the fed-state.	Drug: CG400549 640 mg; multiple oral doses of 640 mg CG400549 (n=6) QD for 5 days in the fed state
Experimental: E4: CG400549 960mg; CG400549 960mg QD on Day 1-5 in the fed-state.	Drug: CG400549 960 mg; multiple oral doses of 960 mg CG400549 (n=6) QD for 5 days in the fed state
Placebo Comparator: P1 Placebo; Placebo 640mg BID on Day 1-5 and QD on Day 6 in the fed-state	Drug: Placebo 640mg; 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; Drug: Placebo 640mg; multiple oral doses of 640 mg placebo (n=2) QD for 5 days in the fed state
Placebo Comparator: P2: Placebo 320mg; Placebo 320mg QD on Day 1-5 in the fed-state	Drug: Placebo 320mg; multiple oral doses of 320 mg placebo (n=2) QD for 5 days in the fed state
Placebo Comparator: P3 Placebo 640mg; Placebo 640mg QD on Day 1-5 in the fed-state.	Drug: placebo 960 mg; multiple oral doses of 960 mg placebo (n=2) QD for 5 days in the fed state
Placebo Comparator: P4: Placebo 960mg; Placebo 960mg QD on Day 1-5 in the fed-state.	Drug: Placebo 640mg; 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; Drug: Placebo 640mg; multiple oral doses of 640 mg placebo (n=2) QD for 5 days in the fed state

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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.	Day1 and Day5

Collaborators and Investigators

• Sponsor: CrystalGenomics, Inc.
• Investigators: Study Chair: Seonggu Ro, PhD, CrystalGenomics, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: February 13, 2013
• First Submitted That Met QC Criteria: May 3, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Estimate): May 7, 2013
• Last Update Submitted That Met QC Criteria: May 3, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: CG400549-1-02