Multiple Ascending Doses Study of CG400549

NCT01848470 | Completed Phase 1

• 1 other identifier: CG400549-1-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  From Time the ICF is signed until Follow up Visit (15 days after study drug administration)

Secondary Outcomes (1)

• Pharmacokinetics-tmax(h), Cmax (ng/mL), Auc (0-24), T1/2(h)

  Day1 and Day5

Study Arms (8)

E1. CG400549 640mg

EXPERIMENTAL

CG400549 640mg BID on Day 1-5 and QD on Day 6 in the fed-state

Drug: CG400549 640mg

E2: CG400549 320mg

EXPERIMENTAL

CG400549 320mg QD on Day 1-5 in the fed-state.

Drug: CG400549 320 mg

E3: CG400549 640mg

EXPERIMENTAL

CG400549 640mg QD on Day 1-5 in the fed-state.

Drug: CG400549 640 mg

E4: CG400549 960mg

EXPERIMENTAL

CG400549 960mg QD on Day 1-5 in the fed-state.

Drug: CG400549 960 mg

P1 Placebo

PLACEBO COMPARATOR

Placebo 640mg BID on Day 1-5 and QD on Day 6 in the fed-state

Drug: Placebo 640mg

P2: Placebo 320mg

PLACEBO COMPARATOR

Placebo 320mg QD on Day 1-5 in the fed-state

Drug: Placebo 320mg

P3 Placebo 640mg

PLACEBO COMPARATOR

Placebo 640mg QD on Day 1-5 in the fed-state.

Drug: placebo 960 mg

P4: Placebo 960mg

PLACEBO COMPARATOR

Placebo 960mg QD on Day 1-5 in the fed-state.

Drug: Placebo 640mg

Interventions

CG400549 640mg DRUG

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

E1. CG400549 640mg

CG400549 320 mg DRUG

multiple oral doses of 320 mg CG400549 (n=6) QD for 5 days in the fed state

E2: CG400549 320mg

CG400549 640 mg DRUG

multiple oral doses of 640 mg CG400549 (n=6) QD for 5 days in the fed state

E3: CG400549 640mg

CG400549 960 mg DRUG

multiple oral doses of 960 mg CG400549 (n=6) QD for 5 days in the fed state

E4: CG400549 960mg

Placebo 640mg DRUG

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

P1 Placebo

Placebo 320mg DRUG

multiple oral doses of 320 mg placebo (n=2) QD for 5 days in the fed state

P2: Placebo 320mg

placebo 960 mg DRUG

multiple oral doses of 960 mg placebo (n=2) QD for 5 days in the fed state

P3 Placebo 640mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CrystalGenomics, Inc.: lead

Study Sites (1)

PRA International clinical center

Zuidlaren, Netherlands

Location

MeSH Terms

Interventions

CG 400549

Study Officials

• Seonggu Ro, PhD

  CrystalGenomics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: May 7, 2013
• Study Start: May 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

NL (1)