HealthyPhase 1NCT02404922
Multiple Ascending Dose Study in Healthy Volunteers
A Phase 1 study testing CTP-730 in people with Healthy, run by Concert Pharmaceuticals at 1 site in Australia.
Trial summary
This study will assess in healthy male and female subjects the safety, tolerability and pharmacokinetics (PK) profiles of Immediate Release CTP-730 at steady state following 7 days of dosing. Three doses of Immediate Release (IR) CTP-730 capsules will be studied. 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-730
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2015to Jun 2015
- 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 adult males and females between 18 and 50 years of age.
- Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2
Who cannot join
- Medical, psychiatric illness or history of depression that could, in the investigator's opinion, compromise the subject's safety
- Significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions.
- PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcB / 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.
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- Urinalysis positive for 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 Phase I Single Center, Double-Blind, Placebo-Controlled, Multiple Dose-Ascending Study to Evaluate the Pharmacokinetics and Tolerability of CTP-730 Immediate Release at Steady State in Healthy Adults
This study will assess in healthy male and female subjects the safety, tolerability and pharmacokinetics (PK) profiles of Immediate Release CTP-730 at steady state following 7 days of dosing. Three doses of Immediate Release (IR) CTP-730 capsules will be studied.
- Conditions
- Healthy
- Being tested
- CTP-730, Placebo for CTP-730
- Keywords
- Safety/Efficacy Study, Randomized, Double Blind
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTP-730Drug
Placebo for CTP-730Drug
| Study group | Role | What they receive |
|---|---|---|
| CTP-730 Low Dose or Matching Placebo | Experimental | Capsule, once daily. Receives: Drug: CTP-730; Drug: Placebo for CTP-730 |
| CTP-730 Mid Dose or Matching Placebo | Experimental | Capsule, once daily Receives: Drug: CTP-730; Drug: Placebo for CTP-730 |
| CTP-730 High Dose or Matching Placebo | Experimental | Capsule, once daily. Receives: Drug: CTP-730; Drug: Placebo for CTP-730 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Profile
The primary pharmacokinetics parameters of interest will be time to attainment of steady state, and Cmax, Tmax, AUC0-24hr, AUClast and AUCinf at steady state
Measured: 96 hours
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Adverse events categorized by body system and MedDRA term
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJun 2015
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concert Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ginny Braman, Study director, Concert Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404922
- Sponsor's protocol ID
- CP730.1002
- Status last verified
- Jun 2015
- First submitted
- 27 Mar 2015
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single Center, Double-Blind, Placebo-Controlled, Multiple Dose-Ascending Study to Evaluate the Pharmacokinetics and Tolerability of CTP-730 Immediate Release at Steady State in Healthy Adults
- ClinicalTrials.gov ID
- NCT02404922
- Acronym / sponsor ID
- CP730.1002
- Conditions
- Healthy
- Keywords
- Safety/Efficacy Study, Randomized, Double Blind
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Apr 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.
This study will assess in healthy male and female subjects the safety, tolerability and pharmacokinetics (PK) profiles of Immediate Release CTP-730 at steady state following 7 days of dosing. Three doses of Immediate Release (IR) CTP-730 capsules 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
- 3
| Arm | Type | Receives |
|---|---|---|
| CTP-730 Low Dose or Matching Placebo | Experimental | Drug: CTP-730, Drug: Placebo for CTP-730Capsule, once daily. |
| CTP-730 Mid Dose or Matching Placebo | Experimental | Drug: CTP-730, Drug: Placebo for CTP-730Capsule, once daily |
| CTP-730 High Dose or Matching Placebo | Experimental | Drug: CTP-730, Drug: Placebo for CTP-730Capsule, once daily. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult males and females between 18 and 50 years of age.
- Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2
Key exclusion criteria (10 listed)
- Medical, psychiatric illness or history of depression that could, in the investigator's opinion, compromise the subject's safety
- Significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions.
- PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcB / 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.
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-730 | Drug | CTP-730 High Dose or Matching Placebo, CTP-730 Low Dose or Matching Placebo, CTP-730 Mid Dose or Matching Placebo |
| Placebo for CTP-730 | Drug | CTP-730 High Dose or Matching Placebo, CTP-730 Low Dose or Matching Placebo, CTP-730 Mid Dose or Matching Placebo |
Primary outcome
Pharmacokinetic Profile
Time frame: 96 hours
The primary pharmacokinetics parameters of interest will be time to attainment of steady state, and Cmax, Tmax, AUC0-24hr, AUClast and AUCinf at steady state
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 24 hours
Adverse events categorized by body system and MedDRA term
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 5 Feb 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.
Ginny Braman 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-730 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 10 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 5 Feb 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?
Pharmacokinetic Profile (time frame: 96 hours). 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 5 Feb 2016.