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Trial record 1 of 7 for:    CTP-656
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Food Effect Study of CTP-656 in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02680249
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

Brief Summary:
Three way crossover study to assess the bioavailability of 656 under fed and fasted conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: CTP-656 Phase 1

Detailed Description:

This study will assess in healthy male subjects a solid oral dose formulation of CTP-656 under fasted and fed conditions.

Primary:

• To characterize the relative bioavailability and pharmacokinetic profile of a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.

Secondary:

  • To characterize the pharmacokinetic profile of metabolites of CTP-656 following a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.
  • To assess the safety and tolerability following a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1 Single Center, Open-Label, Randomized, Three-Way Crossover Study of the Relative Bioavailability of a Single Dose of CTP-656 in a Fasted, Fed Low-Fat and Fed Moderate-Fat Condition in Healthy Male Subjects
Study Start Date : February 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: CTP-656 Fed, low fat
Single dose of CTP-656 150 mg administered after a low-fat breakfast
Drug: CTP-656
Experimental: CTP-656 Fasted
Single dose of CTP-656 150 mg administered fasted
Drug: CTP-656
Experimental: CTP-656 Fed, high fat
Single dose of CTP-656 150 mg administered after a moderate-fat breakfast
Drug: CTP-656



Primary Outcome Measures :
  1. Measurement of CTP-656 in plasma under fed and fasted conditions [ Time Frame: 96 hours ]
    Geometric mean ratio of moderate-fat versus low-fat or fasted



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults between 18 and 50 years of age, inclusive
  • Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive, at screening

Exclusion Criteria:

  • History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal (including nephrolithiasis), hepatic, including history of Gilbert's syndrome or gastrointestinal (GI) conditions
  • PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcF interval > 450 msec obtained at screening visit or prior to the first dose of study drug
  • Liver function tests greater than the upper limit of normal.
  • Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening
  • Urinalysis positive for greater than trace blood, protein or glucose
  • A positive screen for alcohol, drugs of abuse, or tobacco use.
  • Inability to comply with dietary restrictions during study participation.
  • Donation or blood collection or acute loss of blood prior to 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): NCT02680249


Locations
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Australia, South Australia
CMAX
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Concert Pharmaceuticals
Investigators
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Study Director: Lana Pilja Concert Pharmaceuticals, Inc.

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Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02680249     History of Changes
Other Study ID Numbers: CP656.1003
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016
Keywords provided by Concert Pharmaceuticals:
Safety, Bioavailability and Pharmacokinetics