HealthyPhase 1NCT02680249
Food Effect Study of CTP-656 in Healthy Male Volunteers
A Phase 1 study testing CTP-656 in people with Healthy, run by Concert Pharmaceuticals at 1 site in Australia.
Trial summary
Three way crossover study to assess the bioavailability of 656 under fed and fasted conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CTP-656
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2016to Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Three way crossover study to assess the bioavailability of 656 under fed and fasted conditions.
Read the 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.
- Conditions
- Healthy
- Being tested
- CTP-656
- Keywords
- Safety, Bioavailability and Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTP-656Drug
| Study group | Role | What they receive |
|---|---|---|
| CTP-656 Fed, low fat | Experimental | Single dose of CTP-656 150 mg administered after a low-fat breakfast Receives: Drug: CTP-656 |
| CTP-656 Fasted | Experimental | Single dose of CTP-656 150 mg administered fasted Receives: Drug: CTP-656 |
| CTP-656 Fed, high fat | Experimental | Single dose of CTP-656 150 mg administered after a moderate-fat breakfast Receives: Drug: CTP-656 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of CTP-656 in plasma under fed and fasted conditions
Geometric mean ratio of moderate-fat versus low-fat or fasted
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concert Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lana Pilja, Study director, Concert Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680249
- Sponsor's protocol ID
- CP656.1003
- Status last verified
- Apr 2016
- First submitted
- 3 Feb 2016
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02680249
- Acronym / sponsor ID
- CP656.1003
- Conditions
- Healthy
- Keywords
- Safety, Bioavailability and Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Three way crossover study to assess the bioavailability of 656 under fed and fasted conditions.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CTP-656 Fed, low fat | Experimental | Drug: CTP-656Single dose of CTP-656 150 mg administered after a low-fat breakfast |
| CTP-656 Fasted | Experimental | Drug: CTP-656Single dose of CTP-656 150 mg administered fasted |
| CTP-656 Fed, high fat | Experimental | Drug: CTP-656Single dose of CTP-656 150 mg administered after a moderate-fat breakfast |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTP-656 | Drug | CTP-656 Fasted, CTP-656 Fed, high fat, CTP-656 Fed, low fat |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lana Pilja study director
Concert Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTP-656 in people with Healthy, run by Concert Pharmaceuticals at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of CTP-656 in plasma under fed and fasted conditions (time frame: 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.