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Multiple Ascending Doses Study of CG400549

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ClinicalTrials.gov Identifier: NCT01848470
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : May 7, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: CG400549 640mg Drug: CG400549 320 mg Drug: CG400549 640 mg Drug: CG400549 960 mg Drug: Placebo 640mg Drug: Placebo 320mg Drug: placebo 960 mg Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of Multiple Ascending Doses of CG400549 in Healthy Volunteers
Study Start Date : May 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

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

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) QD for 5 days in the fed state




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: From Time the ICF is signed until Follow up Visit (15 days after study drug administration) ]

Secondary Outcome Measures :
  1. Pharmacokinetics-tmax(h), Cmax (ng/mL), Auc (0-24), T1/2(h) [ Time Frame: Day1 and Day5 ]
    To determine the pharmacokinetics of CG400549 following oral administration of multiple ascending doses of CG400549 in healthy male subjects.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848470


Locations
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Netherlands
PRA International clinical center
Zuidlaren, Netherlands
Sponsors and Collaborators
CrystalGenomics, Inc.
Investigators
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Study Chair: Seonggu Ro, PhD CrystalGenomics, Inc.

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Responsible Party: CrystalGenomics, Inc.
ClinicalTrials.gov Identifier: NCT01848470     History of Changes
Other Study ID Numbers: CG400549-1-02
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013