Alcohol Use DisorderPhase 1NCT06147622
A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine
A Phase 1 study testing Prazosin + cyproheptadine and KT110 in people with Alcohol Use Disorder, run by Kinnov Therapeutics at 1 site in France.
Trial summary
The study is an open-label, randomized,2-period, single dose, crossover study in 8 healthy male/female volunteers. Subjects will be randomized to the following sequences: (A) Period 1: KT110 - wash-out period - Period 2: Alpress and Periactin marketed tablets ; Or (B) Period 1: Alpress and Periactin marketed tablets … Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Prazosin + cyproheptadine and KT110
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2024to 31 Dec 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male/female subject
- Females of childbearing potential and male participant must agree to use an adequate and highly effective method of contraception
- Negative serum pregnancy test at screening for woman of childbearing potential only
- Non-smoker subject or smoker of not more than 5 cigarettes a day
- Body Mass Index (BMI) between 18.5 and 30 kg/m2 inclusive, at screening
Who cannot join
- Any contraindication to Prazosin or Cyproheptadine treatments;
- Frequent headaches and / or migraine, recurrent nausea and / or vomiting;
- Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease equal to or greater than 20 mmHg in systolic blood pressure (SBP) and a decrease equal to or greater than 10 mmHg in diastolic blood pressure (DBP) within two minutes of changing from supine to standing position;
- Blood donation (including as part of a clinical trial) in the 2 months before administration
- Any drug intake (except paracetamol or contraception) during the month prior to the first administration;
- History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day)
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- Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day);
- Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests
- Positive results of screening for drugs of abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Cross-over Study in Healthy Volunteers to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine Following Single Dose Oral Administration of KT110 Tablet and Following Administration of Alpress and Periactin Marketed Tablets
The study is an open-label, randomized,2-period, single dose, crossover study in 8 healthy male/female volunteers. Subjects will be randomized to the following sequences:
(A) Period 1: KT110 - wash-out period - Period 2: Alpress and Periactin marketed tablets ; Or (B) Period 1: Alpress and Periactin marketed tablets - wash-out period - Period 2: KT110
- Conditions
- Alcohol Use Disorder
- Being tested
- Prazosin + cyproheptadine, KT110
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prazosin + cyproheptadineDrug
Subjects will receive prazosin + cyproheptadine on day 1 of period 1 or on day 1 of period 2 depending on randomization.
KT110Drug
Subjects will receive KT110 on day 1 of period 1 or on day 1 of period 2 depending on randomization.
| Study group | Role | What they receive |
|---|---|---|
| KT110 | Experimental | Subjects will be randomized to receive KT110 on period 1 or period 2 Receives: Drug: KT110 |
| Prazosin + cyproheptadine | Experimental | Subjects will be randomized to receive prazosin + cyproheptadine on period 1 or period 2 Receives: Drug: Prazosin + cyproheptadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (area under the curve) 0-t
Area under the curve from time 0 to the last measurable concentration at time t
Measured: Day 4
AUC 0-inf
Area under the curve from time 0 extrapolated to infinity (only for Cyproheptadine)
Measured: Day 4
Cmax
Maximum observed concentration
Measured: Day 4
Tmax
Time of maximum observed concentration
Measured: Day 4
T1/2
Apparent elimination half-life
Measured: Day 4
K el
Apparent Elimination rate constant
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start23 Apr 2024
- Primary completion31 Jul 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- open-label, randomized, 2-period, single dose, crossover study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinnov Therapeutics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147622
- Sponsor's protocol ID
- OP111821.KIN
- Status last verified
- Mar 2025
- First submitted
- 15 Nov 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Cross-over Study in Healthy Volunteers to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine Following Single Dose Oral Administration of KT110 Tablet and Following Administration of Alpress and Periactin Marketed Tablets
- ClinicalTrials.gov ID
- NCT06147622
- Acronym / sponsor ID
- OP111821.KIN
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Kinnov TherapeuticsUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Nov 2023 (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.
The study is an open-label, randomized,2-period, single dose, crossover study in 8 healthy male/female volunteers. Subjects will be randomized to the following sequences:
(A) Period 1: KT110 - wash-out period - Period 2: Alpress and Periactin marketed tablets ; Or (B) Period 1: Alpress and Periactin marketed tablets - wash-out period - Period 2: KT110
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label, randomized, 2-period, single dose, crossover study
| Arm | Type | Receives |
|---|---|---|
| KT110 | Experimental | Drug: KT110Subjects will be randomized to receive KT110 on period 1 or period 2 |
| Prazosin + cyproheptadine | Experimental | Drug: Prazosin + cyproheptadineSubjects will be randomized to receive prazosin + cyproheptadine on period 1 or period 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male/female subject
- Females of childbearing potential and male participant must agree to use an adequate and highly effective method of contraception
- Negative serum pregnancy test at screening for woman of childbearing potential only
- Non-smoker subject or smoker of not more than 5 cigarettes a day
- Body Mass Index (BMI) between 18.5 and 30 kg/m2 inclusive, at screening
Key exclusion criteria (9 listed)
- Any contraindication to Prazosin or Cyproheptadine treatments;
- Frequent headaches and / or migraine, recurrent nausea and / or vomiting;
- Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease equal to or greater than 20 mmHg in systolic blood pressure (SBP) and a decrease equal to or greater than 10 mmHg in diastolic blood pressure (DBP) within two minutes of changing from supine to standing position;
- Blood donation (including as part of a clinical trial) in the 2 months before administration
- Any drug intake (except paracetamol or contraception) during the month prior to the first administration;
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 |
|---|---|---|
| Prazosin + cyproheptadineSubjects will receive prazosin + cyproheptadine on day 1 of period 1 or on day 1 of period 2 depending on randomization. | Drug | Prazosin + cyproheptadine |
| KT110Subjects will receive KT110 on day 1 of period 1 or on day 1 of period 2 depending on randomization. | Drug | KT110 |
Primary outcome
AUC (area under the curve) 0-t
Time frame: Day 4
Area under the curve from time 0 to the last measurable concentration at time t
AUC 0-inf
Time frame: Day 4
Area under the curve from time 0 extrapolated to infinity (only for Cyproheptadine)
Cmax
Time frame: Day 4
Maximum observed concentration
Tmax
Time frame: Day 4
Time of maximum observed concentration
T1/2
Time frame: Day 4
Apparent elimination half-life
K el
Time frame: Day 4
Apparent Elimination rate constant
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 13 Mar 2025.
- Individual participant dataSharing planned: No
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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 Prazosin + cyproheptadine and KT110 in people with Alcohol Use Disorder, run by Kinnov Therapeutics at 1 site in France.
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 9 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 13 Mar 2025. 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 France. 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?
AUC (area under the curve) 0-t (time frame: Day 4). The study lists 6 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 13 Mar 2025.