Healthy SubjectsPhase 1NCT03072056
A Pharmacokinetic Study of MIN-101 and Its Metabolites in Healthy Subjects to Compare MIN-101 in Poor and Extensive Metabolizers
A Phase 1 study testing MIN-101 in people with Healthy Subjects, run by Minerva Neurosciences at 1 site in Ireland.
Trial summary
To evaluate the pharmacokinetic (PK) profile of MIN-101 and its metabolites in extensive (EM) and poor (PM) metabolizers To evaluate the relationship between plasma levels of MIN-101 and changes in QT/QTcF intervals To evaluate safety and tolerability of MIN-101. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- MIN-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIreland
- Study dates
- 9 Jan 2017to 7 Jul 2017
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Confirmed CYP2D6 extensive or poor metabolizer genotype
- Subject has given voluntary written informed consent before performance of any study related procedure
- Subject must be 18 to 45 years of age, inclusive
- Subject must be a healthy male or female as indicated by the following:
- Clinical chemistries, hematology, and urinalysis tests must be within normal, allowable limits (if out of range, and with the exception of potassium, magnesium, and calcium, must be considered clinically significant to be exclusionary) and performed within 21 days of receiving first dose of study drug
- Body mass index of between 18 and 30 kg/m2
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- Normal vital signs after 5 minutes resting in supine position and in standing position after 5 minutes of resting in supine position:
- 95 mm Hg < systolic blood pressure < 140 mm Hg
- 50 mm Hg < diastolic blood pressure < 90 mm Hg
- 50 bpm < heart rate < 90 bpm
- Systolic blood pressure decrease of less than 20 mm Hg within 3 minutes of standing
- Diastolic blood pressure decrease of less than 10 mm Hg within 3 minutes of standing
- Normal 12-lead automatic ECG: 120 ms < PR < 210 ms, QRS < 120 ms, QTc (Fridericia) ≤ 430 msec for males and ≤ 440 ms for females
- Agree to abstain from all medication (except for allowed birth control in #5 below), including non-prescription and prescription medication (including vitamins and natural or herbal remedies, e.g. St. John's Wort) for 21 days before the first study day until discharge from the study (end of post study medical).
- Subject agrees to use an adequate method of birth control (excluding oral hormonal contraception). Subjects who are sexually active must use, with their partner, 2 approved methods of highly effective contraception from the time of study drug administration until 90 days after the last dose of study drug.
Who cannot join
- A history of clinically significant gastrointestinal disease, especially peptic ulcerations, gastrointestinal bleeding, ulcerative colitis, Crohn's disease or Irritable Bowel Syndrome; renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic or psychiatric disease, especially those with a past history of depression, suicidal ideation or suicide attempts, or cardiovascular disease, or any other condition which, in the opinion of the principle investigator, would jeopardize the safety of the subject or impact the validity of the study results
- Acute diarrhea or constipation in the 7 days before the predicted first study day. If screen occurs > 7 days before first study day, this criterion will be determined on first study day.
- Subject has donated blood within 90 days or plasma within 30 days of study dosing
- Regular alcohol consumption in males > 21 units per week and females > 14 units per week (1 Unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Subject has a borderline or long QTc interval by the Fridericia correction method, as defined by screening readings of > 430 msec for males and > 440 for females or a personal or familial history of long QT syndrome
- Subject has participated in a clinical trial within 90 days prior to study initiation
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- Females of child bearing potential who are pregnant, breast feeding or who are either not surgically sterile, postmenopausal, or are sexually active and not using an acceptable form of contraception
- Subject has used any over-the-counter (OTC) medication, dietary or herbal supplements, including vitamins, within 21 days prior to study entry
- Subject has used any prescription medication within 21 days prior to the Day -1
- Subject has been treated with any known CYP2D6 or CYP3A4 enzymes altering drugs within 30 days prior to the study
- Subject has smoked or used tobacco products within 2 months prior to or during the study
- Subject has sought advice from or been referred to a GP or counselor for abuse or misuse of alcohol, non-medical drugs, medicinal drugs or other substance abuse, e.g.
- solvents
- Subject has a positive blood screen for HIV, Hepatitis B surface antigen (HBsAg), and Hepatitis C antibody and/or a positive urine screen for drugs of abuse or positive alcohol breath test at screening, or history of positive urine drugs of abuse screens
- Any current or previous use of drugs such as opiates, cocaine, ecstasy, or intravenous amphetamines Subjects who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs-of-abuse test and have been abstinent from cannabis use for at least 3 months
- Subject has an uncontrolled inter-current illness (i.e., active infection)
- Subject has had major surgery within 28 days of study entry, or 12 months prior to study for gastrointestinal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, 3-Period, Single-Ascending Dose, Crossover Study in Healthy Subjects to Compare PK Properties of MIN-101 and Its Metabolites Poor and Extensive Metabolizers as Defined by Cytochrome P450 2D6 Genotype
- To evaluate the pharmacokinetic (PK) profile of MIN-101 and its metabolites in extensive (EM) and poor (PM) metabolizers
- To evaluate the relationship between plasma levels of MIN-101 and changes in QT/QTcF intervals
- To evaluate safety and tolerability of MIN-101.
- Conditions
- Healthy Subjects
- Being tested
- MIN-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIN-101Drug
| Study group | Role | What they receive |
|---|---|---|
| Extensive Metabolizers, 4 mg | Experimental | subjects will receive 32 mL of MIN-101 as a 0.125 mg/mL oral solution Receives: Drug: MIN-101 |
| Extensive Metabolizers, 8 mg | Experimental | subjects will receive 32 mL of MIN-101 as a 0.25 mg/mL oral solution Receives: Drug: MIN-101 |
| Extensive Metabolizers, 16 mg | Experimental | subjects will receive 32 mL of MIN-101 as a 0.5 mg/mL oral solution Receives: Drug: MIN-101 |
| Poor Metabolizers, 4 mg | Experimental | subjects will receive 32 mL of MIN-101 as a 0.125 mg/mL oral solution Receives: Drug: MIN-101 |
| Poor Metabolizers, 8 mg | Experimental | subjects will receive 32 mL of MIN-101 as a 0.25 mg/mL oral solution Receives: Drug: MIN-101 |
| Poor Metabolizers, 16 mg | Experimental | subjects will receive 32 mL of MIN-101 as a 0.5 mg/mL oral solution Receives: Drug: MIN-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma PK parameter, Cmax
To estimate the relative bioavailability of MIN-l0l following MIN-101 administration. Plasma samples will be analyzed for MIN-101 and its metabolites using a validated LC-MS/MS method
Measured: 0, .25, .5, .75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14, 16, 24, 28, 32, 36, 48, 52, 56, 60, 72, and 76 hr post-dose on Day 1 of 3 periods (each period is up to 6 days). One sample from PM subjects at hr 98±2
Plasma PK parameter, Tmax
Measured: from predose up to 76 hours post dose
Plasma PK parameter, Tlag
Measured: from predose up to 72 hours post dose
Plasma PK parameter,partial AUC (e.g., AUC12, AUC24), AUClast, AUC∞
Measured: from predose up to 72 hours post dose
Plasma PK parameter, λz and t1/2
Measured: from predose up to 72 hours post dose
To evaluate the relationship between plasma levels of MIN-101 and its main metabolites and changes in QT/QTcF intervals in healthy CYP2D6 EM and PM subjects
Measured: at -1.5, -1, -0.25 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 28, 32, 36, 48, 56, 72, and 76 hours post-dose on Day 1 of the 3 periods (each period is up to 6 days).
Secondary outcomes (1)
Safety (AE reporting, safety laboratory parameters analysis, vital signs and 12 lead ECG assessments)
Safety will be assessed through AE reporting, safety laboratory parameters analysis, vital signs and 12 lead ECG assessments
Measured: 3 months and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start9 Jan 2017
- Primary completion7 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minerva Neurosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Jabbari, MD, Principal investigator, BioKinetic Europe Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072056
- Sponsor's protocol ID
- MIN-101C05
- Status last verified
- Aug 2017
- First submitted
- 23 Feb 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, 3-Period, Single-Ascending Dose, Crossover Study in Healthy Subjects to Compare PK Properties of MIN-101 and Its Metabolites Poor and Extensive Metabolizers as Defined by Cytochrome P450 2D6 Genotype
- ClinicalTrials.gov ID
- NCT03072056
- Acronym / sponsor ID
- MIN-101C05
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Minerva NeurosciencesIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 7 Mar 2017 (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.
- To evaluate the pharmacokinetic (PK) profile of MIN-101 and its metabolites in extensive (EM) and poor (PM) metabolizers
- To evaluate the relationship between plasma levels of MIN-101 and changes in QT/QTcF intervals
- To evaluate safety and tolerability of MIN-101.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Extensive Metabolizers, 4 mg | Experimental | Drug: MIN-101subjects will receive 32 mL of MIN-101 as a 0.125 mg/mL oral solution |
| Extensive Metabolizers, 8 mg | Experimental | Drug: MIN-101subjects will receive 32 mL of MIN-101 as a 0.25 mg/mL oral solution |
| Extensive Metabolizers, 16 mg | Experimental | Drug: MIN-101subjects will receive 32 mL of MIN-101 as a 0.5 mg/mL oral solution |
| Poor Metabolizers, 4 mg | Experimental | Drug: MIN-101subjects will receive 32 mL of MIN-101 as a 0.125 mg/mL oral solution |
| Poor Metabolizers, 8 mg | Experimental | Drug: MIN-101subjects will receive 32 mL of MIN-101 as a 0.25 mg/mL oral solution |
| Poor Metabolizers, 16 mg | Experimental | Drug: MIN-101subjects will receive 32 mL of MIN-101 as a 0.5 mg/mL oral solution |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Confirmed CYP2D6 extensive or poor metabolizer genotype
- Subject has given voluntary written informed consent before performance of any study related procedure
- Subject must be 18 to 45 years of age, inclusive
- Subject must be a healthy male or female as indicated by the following:
- Agree to abstain from all medication (except for allowed birth control in #5 below), including non-prescription and prescription medication (including vitamins and natural or herbal remedies, e.g. St. John's Wort) for 21 days before the first study day until discharge from the study (end of post study medical).
Key exclusion criteria (17 listed)
- A history of clinically significant gastrointestinal disease, especially peptic ulcerations, gastrointestinal bleeding, ulcerative colitis, Crohn's disease or Irritable Bowel Syndrome; renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic or psychiatric disease, especially those with a past history of depression, suicidal ideation or suicide attempts, or cardiovascular disease, or any other condition which, in the opinion of the principle investigator, would jeopardize the safety of the subject or impact the validity of the study results
- Acute diarrhea or constipation in the 7 days before the predicted first study day. If screen occurs > 7 days before first study day, this criterion will be determined on first study day.
- Subject has donated blood within 90 days or plasma within 30 days of study dosing
- Regular alcohol consumption in males > 21 units per week and females > 14 units per week (1 Unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Subject has a borderline or long QTc interval by the Fridericia correction method, as defined by screening readings of > 430 msec for males and > 440 for females or a personal or familial history of long QT syndrome
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 |
|---|---|---|
| MIN-101 | Drug | Extensive Metabolizers, 16 mg, Extensive Metabolizers, 4 mg, Extensive Metabolizers, 8 mg, Poor Metabolizers, 16 mg, Poor Metabolizers, 4 mg, Poor Metabolizers, 8 mg |
Primary outcome
Plasma PK parameter, Cmax
Time frame: 0, .25, .5, .75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14, 16, 24, 28, 32, 36, 48, 52, 56, 60, 72, and 76 hr post-dose on Day 1 of 3 periods (each period is up to 6 days). One sample from PM subjects at hr 98±2
To estimate the relative bioavailability of MIN-l0l following MIN-101 administration. Plasma samples will be analyzed for MIN-101 and its metabolites using a validated LC-MS/MS method
Plasma PK parameter, Tmax
Time frame: from predose up to 76 hours post dose
Plasma PK parameter, Tlag
Time frame: from predose up to 72 hours post dose
Plasma PK parameter,partial AUC (e.g., AUC12, AUC24), AUClast, AUC∞
Time frame: from predose up to 72 hours post dose
Plasma PK parameter, λz and t1/2
Time frame: from predose up to 72 hours post dose
To evaluate the relationship between plasma levels of MIN-101 and its main metabolites and changes in QT/QTcF intervals in healthy CYP2D6 EM and PM subjects
Time frame: at -1.5, -1, -0.25 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 28, 32, 36, 48, 56, 72, and 76 hours post-dose on Day 1 of the 3 periods (each period is up to 6 days).
1 secondary outcome
Safety (AE reporting, safety laboratory parameters analysis, vital signs and 12 lead ECG assessments)
Time frame: 3 months and 7 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 31 Aug 2017.
- 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.
Daniel Jabbari, MD principal investigator
BioKinetic Europe Ltd
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 MIN-101 in people with Healthy Subjects, run by Minerva Neurosciences at 1 site in Ireland.
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 15 inclusion and 17 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 31 Aug 2017. 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 Ireland. 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?
Plasma PK parameter, Cmax (time frame: 0, .25, .5, .75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14, 16, 24, 28, 32, 36, 48, 52, 56, 60, 72, and 76 hr post-dose on Day 1 of 3 periods (each period is up to 6 days). One sample from PM subjects at hr 98±2). 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 31 Aug 2017.