Health VolunteersPhase 1NCT05467709
Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Healthy Subjects
A Phase 1 study testing Midazolam and CTP-543 in people with Health Volunteers, run by Concert Pharmaceuticals at 1 site in United States.
Trial summary
This is a single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to determine the effect of CTP-543 on the pharmacokinetics (PK) of midazolam in healthy adult subjects Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Volunteers
- What is being tested?
- Midazolam and CTP-543
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2022to 7 Jul 2022
- 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
- Healthy, adult, male or female, aged 18-60
- Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening
- If of reproductive age, willing and able to use a medically highly effective form of birth control 4 weeks prior to first dose, during the study and for 30 days following last dose of study medication
- Capable of giving informed consent and complying with study procedures
Who cannot join
- History or presence of clinically significant medical or psychiatric condition or disease
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
- History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) > 450 msec for males or QTcF > 470 msec for females at screening visit or prior to the first dosing
- Abnormal liver function at screening
- Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
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- Positive results for coronavirus infection (COVID-19) at screening or check-in
- Positive drug or alcohol results at screening or check-in
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- Participation in another clinical study within 30 days prior to, and 30 days after the first dosing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014
About this study
Official title: A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Healthy Subjects
This is a single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to determine the effect of CTP-543 on the pharmacokinetics (PK) of midazolam in healthy adult subjects
- Conditions
- Health Volunteers
- Being tested
- Midazolam, CTP-543
- Keywords
- CTP-543
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
2 mg Day 1 and Day 16
CTP-543Drug
12 mg q12 hour for 14 consecutive days starting on Day 3
| Study group | Role | What they receive |
|---|---|---|
| CTP-543 | Experimental | Subjects will receive a single 2 mg dose of midazolam on Day 1. Starting on Day 3, 12 mg dose of CTP-543 will be administered (q12 hrs) for 14 consecutive days (up to Day 16). On Day 16, subjects will be co-administered a single 2 mg midazolam dose along with the morning dose of CTP-543. The second dose of CTP-543 will be administered as scheduled on Day 16. Receives: Drug: Midazolam; Drug: CTP-543 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed concentration
Measured: Day 14, 15, 16, Discharge (Day 17)
Tmax
Time to reach maximum observed concentration
Measured: Day 14, 15, 16, Discharge (Day 17)
AUC0-inf
Area under the concentration-time curve from time 0 extrapolated to infinity
Measured: Day 14, 15, 16, Discharge (Day 17)
AUC0-t
Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration
Measured: Day 14, 15, 16, Discharge (Day 17)
λz
Terminal elimination rate constant
Measured: Day 14, 15, 16, Discharge (Day 17)
t1/2
Apparent terminal half-life
Measured: Day 14, 15, 16, Discharge (Day 17)
CL/F
Apparent total plasma clearance (Midazolam only)
Measured: Day 1, 2, 16, Discharge (Day 17)
Vz/F
Apparent volume of distribution (Midazolam only)
Measured: Day 1, 2, 16, Discharge (Day 17)
Secondary outcomes (1)
Assessment of Safety and Tolerability following administration of CTP-543
Number of adverse events, including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject
Measured: Screening (within 21 days prior to Day 1) through follow-up (approximately 7 days after last study drug administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start21 Jun 2022
- Primary completion30 Jun 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT05467709
- Sponsor's protocol ID
- CP543.1012
- Status last verified
- Jul 2022
- First submitted
- 30 Jun 2022
- Last updated
- 20 Jul 2022
- 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 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Healthy Subjects
- ClinicalTrials.gov ID
- NCT05467709
- Acronym / sponsor ID
- CP543.1012
- Conditions
- Health Volunteers
- Keywords
- CTP-543
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 20 Jul 2022 (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 single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to determine the effect of CTP-543 on the pharmacokinetics (PK) of midazolam in healthy adult subjects
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTP-543 | Experimental | Drug: Midazolam, Drug: CTP-543Subjects will receive a single 2 mg dose of midazolam on Day 1. Starting on Day 3, 12 mg dose of CTP-543 will be administered (q12 hrs) for 14 consecutive days (up to Day 16). On Day 16, subjects will be co-administered a single 2 mg midazolam dose along with the morning dose of CTP-543. The second dose of CTP-543 will be administered as scheduled on Day 16. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, adult, male or female, aged 18-60
- Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening
- If of reproductive age, willing and able to use a medically highly effective form of birth control 4 weeks prior to first dose, during the study and for 30 days following last dose of study medication
- Capable of giving informed consent and complying with study procedures
Key exclusion criteria (10 listed)
- History or presence of clinically significant medical or psychiatric condition or disease
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
- History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) > 450 msec for males or QTcF > 470 msec for females at screening visit or prior to the first dosing
- Abnormal liver function at screening
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 |
|---|---|---|
| Midazolam2 mg Day 1 and Day 16 | Drug | CTP-543 |
| CTP-54312 mg q12 hour for 14 consecutive days starting on Day 3 | Drug | CTP-543 |
Primary outcome
Cmax
Time frame: Day 14, 15, 16, Discharge (Day 17)
Maximum observed concentration
Tmax
Time frame: Day 14, 15, 16, Discharge (Day 17)
Time to reach maximum observed concentration
AUC0-inf
Time frame: Day 14, 15, 16, Discharge (Day 17)
Area under the concentration-time curve from time 0 extrapolated to infinity
AUC0-t
Time frame: Day 14, 15, 16, Discharge (Day 17)
Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration
λz
Time frame: Day 14, 15, 16, Discharge (Day 17)
Terminal elimination rate constant
t1/2
Time frame: Day 14, 15, 16, Discharge (Day 17)
Apparent terminal half-life
CL/F
Time frame: Day 1, 2, 16, Discharge (Day 17)
Apparent total plasma clearance (Midazolam only)
Vz/F
Time frame: Day 1, 2, 16, Discharge (Day 17)
Apparent volume of distribution (Midazolam only)
1 secondary outcome
Assessment of Safety and Tolerability following administration of CTP-543
Time frame: Screening (within 21 days prior to Day 1) through follow-up (approximately 7 days after last study drug administration)
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 20 Jul 2022.
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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 Midazolam and CTP-543 in people with Health 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 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 20 Jul 2022. 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?
Cmax (time frame: Day 14, 15, 16, Discharge (Day 17)). The study lists 8 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 20 Jul 2022.