Multiple Ascending Doses Study of CG400549

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848470
• Other study ID #: CG400549-1-02
• Status: Completed
• Phase: Phase 1
• First received: February 13, 2013
• Last updated: May 3, 2013
• Start date: May 2010
• Est. completion date: March 2011

Study information

• Verified date: May 2013
• Source: CrystalGenomics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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
• CG400549 320 mg
multiple oral doses of 320 mg CG400549 (n=6) QD for 5 days in the fed state
• CG400549 640 mg
multiple oral doses of 640 mg CG400549 (n=6) QD for 5 days in the fed state
• CG400549 960 mg
multiple oral doses of 960 mg CG400549 (n=6) QD for 5 days in the fed state
• 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
• Placebo 320mg
multiple oral doses of 320 mg placebo (n=2) QD for 5 days in the fed state
• placebo 960 mg
multiple oral doses of 960 mg placebo (n=2) QD for 5 days in the fed state
• Placebo 640mg
multiple oral doses of 640 mg placebo (n=2) QD for 5 days in the fed state

Locations

Country	Name	City	State
Netherlands	PRA International clinical center	Zuidlaren

Sponsors (1)

Lead Sponsor	Collaborator
CrystalGenomics, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		From Time the ICF is signed until Follow up Visit (15 days after study drug administration)	Yes
Secondary	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	No