Healthy VolunteersPhase 1NCT04743414
Drug-drug Interaction Study of CTP-543 and Itraconazole in Healthy Adult Subjects
A Phase 1 study testing CTP-543 in people with Healthy Volunteers, run by Concert Pharmaceuticals at 1 site in United States.
Trial summary
This is a Phase 1 open-label study of the effect of itraconazole on the pharmacokinetics of CTP-543 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CTP-543
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to 5 Apr 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs
- If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication.
- Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol
Who cannot join
- History or presence of clinically significant medical or psychiatric condition or disease
- History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
- Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- A positive test or history of incompletely treated or untreated tuberculosis
- Donation of > 499 mL of blood or plasma within 56 days of Screening (during a clinical trial or at a blood bank donation) and for 30 days after last dose of study drug
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami
Miami, Florida, 33014
About this study
Official title: A Phase 1 Open-Label Study to Assess the Effect of a Strong CYP3A4 Inhibitor, Itraconazole, on the Single Dose Pharmacokinetic Profile of CTP-543 in Healthy Adult Subjects
This is a Phase 1 open-label study of the effect of itraconazole on the pharmacokinetics of CTP-543 in healthy subjects.
- Conditions
- Healthy Volunteers
- Being tested
- CTP-543
- Keywords
- Itraconazole, Drug-drug interaction, CTP-543
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTP-543Drug
Itraconazole in solution dosage form
| Study group | Role | What they receive |
|---|---|---|
| CTP-543 | Experimental | On Day 1, participants will receive a single oral dose of CTP-543. Following a washout period on Days 2 and 3, participants will receive a single oral dose of itraconazole on Day 4 through Day 8, with a single oral dose of CTP-543 being co-administered on Day 7. Receives: Drug: CTP-543 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Area Under the Plasma Concentration-Time Profile
Measured: 48 hours
AUC0-inf
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time
Measured: 48 hours
Cmax
Maximum observed concentration of drug in plasma
Measured: 48 hours
Tmax
Time to reach maximum observed concentration of drug in plasma
Measured: 48 hours
Secondary outcomes (1)
Number of Participants with Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Measured: Up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start2 Mar 2021
- Primary completion27 Mar 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concert Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743414
- Sponsor's protocol ID
- CP543.1007
- Status last verified
- Apr 2021
- First submitted
- 4 Feb 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Study to Assess the Effect of a Strong CYP3A4 Inhibitor, Itraconazole, on the Single Dose Pharmacokinetic Profile of CTP-543 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04743414
- Acronym / sponsor ID
- CP543.1007
- Conditions
- Healthy Volunteers
- Keywords
- Itraconazole, Drug-drug interaction, CTP-543
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 27 Mar 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 8 Feb 2021 (actual)
- 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 is a Phase 1 open-label study of the effect of itraconazole on the pharmacokinetics of CTP-543 in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTP-543 | Experimental | Drug: CTP-543On Day 1, participants will receive a single oral dose of CTP-543. Following a washout period on Days 2 and 3, participants will receive a single oral dose of itraconazole on Day 4 through Day 8, with a single oral dose of CTP-543 being co-administered on Day 7. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs
- If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication.
- Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol
Key exclusion criteria (7 listed)
- History or presence of clinically significant medical or psychiatric condition or disease
- History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
- Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
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-543Itraconazole in solution dosage form | Drug | CTP-543 |
Primary outcome
AUC0-t
Time frame: 48 hours
Area Under the Plasma Concentration-Time Profile
AUC0-inf
Time frame: 48 hours
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time
Cmax
Time frame: 48 hours
Maximum observed concentration of drug in plasma
Tmax
Time frame: 48 hours
Time to reach maximum observed concentration of drug in plasma
1 secondary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to 40 days
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 8 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-543 in people with Healthy Volunteers, run by Concert Pharmaceuticals at 1 site in United States.
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 5 inclusion and 7 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 8 Apr 2021. 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 United States. 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?
AUC0-t (time frame: 48 hours). The study lists 4 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 8 Apr 2021.