HealthyPhase 1NCT02599792
Healthy Volunteer Solid Oral Dose and Multiple Ascending Dose Evaluation of CTP-656
A Phase 1 study testing CTP-656 and Kalydeco in people with Healthy, run by Concert Pharmaceuticals at 1 site in Australia.
Trial summary
Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and multiple-ascending doses of CTP-656 dosed for 7 days. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CTP-656 and Kalydeco
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2015to 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
- All sexes
- 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 food and beverage 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 Two-Part Phase 1 Healthy Volunteer Study: A Crossover Comparison of CTP-656 Solid Dose Formulation vs. Kalydeco® and a Double-Blind, Placebo-Controlled, Ascending Multiple Dose Evaluation of CTP-656
Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and multiple-ascending doses of CTP-656 dosed for 7 days.
Read the detailed description
This two-part study will assess in healthy male and female subjects a solid oral dose formulation of CTP-656 vs. Kalydeco® and the safety, tolerability and pharmacokinetic profiles of escalating CTP-656 solid oral doses following 7 days of dosing. In Part B, three doses of CTP-656 ranging from 75 mg up to 300 mg per day will be studied.
- Conditions
- Healthy
- Being tested
- CTP-656, Placebo for CTP-656, Kalydeco
- Keywords
- Safety and Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTP-656Drug
Placebo for CTP-656Drug
KalydecoDrug
| Study group | Role | What they receive |
|---|---|---|
| CTP-656, 150 mg | Experimental | Single Oral Dose Receives: Drug: CTP-656 |
| Kalydeco, 150 mg | Active comparator | Single oral dose Receives: Drug: Kalydeco |
| CTP-656, 75 mg or matching placebo | Experimental | Subjects will be administered 75 mg CTP-656 for 7 days. Receives: Drug: CTP-656; Drug: Placebo for CTP-656 |
| CTP-656, 150 mg or matching placebo | Experimental | Subjects will be administered 150 mg CTP-656 for 7 days. Receives: Drug: CTP-656; Drug: Placebo for CTP-656 |
| CTP-656, high dose or matching placebo | Experimental | Subjects will be administered up to 300 mg CTP-656 for 7 days. Receives: Drug: CTP-656; Drug: Placebo for CTP-656 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
adverse events categorized by body system and MedDRA term
Measured: 7 days
Measure exposure of test articles using area under the concentration time curve (AUC)
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 posted9 Nov 2015 (estimated)
- Study startNov 2015
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 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
- NCT02599792
- Sponsor's protocol ID
- CP656.1002
- Status last verified
- Apr 2016
- First submitted
- 5 Nov 2015
- 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 Two-Part Phase 1 Healthy Volunteer Study: A Crossover Comparison of CTP-656 Solid Dose Formulation vs. Kalydeco® and a Double-Blind, Placebo-Controlled, Ascending Multiple Dose Evaluation of CTP-656
- ClinicalTrials.gov ID
- NCT02599792
- Acronym / sponsor ID
- CP656.1002
- Conditions
- Healthy
- Keywords
- Safety and Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 9 Nov 2015 (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.
Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and multiple-ascending doses of CTP-656 dosed for 7 days.
Detailed description
This two-part study will assess in healthy male and female subjects a solid oral dose formulation of CTP-656 vs. Kalydeco® and the safety, tolerability and pharmacokinetic profiles of escalating CTP-656 solid oral doses following 7 days of dosing. In Part B, three doses of CTP-656 ranging from 75 mg up to 300 mg per day will be studied.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CTP-656, 150 mg | Experimental | Drug: CTP-656Single Oral Dose |
| Kalydeco, 150 mg | Active comparator | Drug: KalydecoSingle oral dose |
| CTP-656, 75 mg or matching placebo | Experimental | Drug: CTP-656, Drug: Placebo for CTP-656Subjects will be administered 75 mg CTP-656 for 7 days. |
| CTP-656, 150 mg or matching placebo | Experimental | Drug: CTP-656, Drug: Placebo for CTP-656Subjects will be administered 150 mg CTP-656 for 7 days. |
| CTP-656, high dose or matching placebo | Experimental | Drug: CTP-656, Drug: Placebo for CTP-656Subjects will be administered up to 300 mg CTP-656 for 7 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- 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, 150 mg, CTP-656, 150 mg or matching placebo, CTP-656, 75 mg or matching placebo, CTP-656, high dose or matching placebo |
| Placebo for CTP-656 | Drug | CTP-656, 150 mg or matching placebo, CTP-656, 75 mg or matching placebo, CTP-656, high dose or matching placebo |
| Kalydeco | Drug | Kalydeco, 150 mg |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 7 days
adverse events categorized by body system and MedDRA term
Measure exposure of test articles using area under the concentration time curve (AUC)
Time frame: 96 hours
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 and Kalydeco 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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 7 days). The study lists 2 primary outcomes in all. 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.