SchizophreniaPhase 1NCT02232529
Pharmacokinetic Study of MIN-101 in Healthy Subjects
A Phase 1 study testing MIN-101 in people with Schizophrenia, run by Minerva Neurosciences at 1 site in United Kingdom.
Trial summary
The aim of the study is to assess how MIN-101 is taken up by the body when given in different amounts and in different formulations. The drug will be given as a single dose in Part 1 of the study and during Part 2 of the study as multiple dose, once daily for 7 days. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- MIN-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Feb 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 males (Part 1 and Part 2) or non-pregnant, non-lactating healthy females (Part 2 only)
- Body mass index (BMI) of 18.0 to 30.0 kg/m2
- Must be CYP2D6 Extensive metabolizer
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must agree to use an adequate method of contraception
Who cannot join
- Subjects who have QTc > 430 in male, > 450 in female confirmed by a repeat ECG
- Any family history of sudden cardiac death and Torsade de Points
- No personal or family history of unexplained presyncope, syncope or orthostatic hypotension
- History of any drug or alcohol abuse in the past 2 years
- History or evidence of any medically diagnosed clinically significant psychiatric disorders
- Suicidal tendencies or history of suicidal attempts
Show all 12Show fewer
- 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)
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
- Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission)
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
- Positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part Study Designed to Evaluate the Pharmacokinetic Profile of MIN-101 and Its Main Metabolites Following Single and Multiple Dose Modified Release Prototype Formulation Administration in Healthy Cytochrome P450 2D6 Extensive Metabolizer Male and Female Subjects, and to Evaluate the Relationship Between the Pharmacokinetic Profile of MIN-101 and Its Main Metabolites and Cardiovascular Parameters.
The aim of the study is to assess how MIN-101 is taken up by the body when given in different amounts and in different formulations. The drug will be given as a single dose in Part 1 of the study and during Part 2 of the study as multiple dose, once daily for 7 days. The ultimate aim is to find an optimal formulation which can be developed as a once daily dose for the treatment of schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- MIN-101, Placebo
- Keywords
- modified release formulation, pharmacokinetics
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIN-101Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Part 1: MIN-101 | Experimental | MIN-101
modified release formulation (MR),single oral dose between 16 and 64 mg Receives: Drug: MIN-101 |
| Part 2: MIN-101 low dose | Experimental | MIN-101
single daily oral dose, low dose MR formulation, from Day 1 to Day 7 Receives: Drug: MIN-101 |
| Part 2: placebo | Placebo comparator | placebo MIN-101
daily oral dose from Day 1 to Day 7 Receives: Drug: Placebo |
| Part 2: MIN-101 high dose | Experimental | MIN-101
single daily oral dose, low dose MR formulation, from Day 1 to Day 7 Receives: Drug: MIN-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 Pharmacokinetic profile of MIN-101 and its main metabolites (AUC (0-last), Tmax, Cmax, AUC (0-inf), %AUCextrap, Lambda z, T1/2 and parent:metabolites ratio
Measured: predose and 0.5h, 1h, 1.5h, 2h, 2.5h, 3H, 4H, 6h, 8h, 10h, 12h, 14h, 16h, 20h, 24h, 48h and 72h post-dose
Part 2 - Pharmacokinetic profile of MIN-101 and its main metabolites - Absolute QT intervals and QT intervals corrected using Fridericia formula (QTcF)
Measured: predose to Day 8
Secondary outcomes (7)
Part 1 Safety and tolerability (incidence of adverse events, safety laboratory, 12-lead ECGs, vital signs, physical examination) -
Measured: from predose up to 72 h post dosing
Part 1 Pharmacokinetic profile of MIN-101 in fed and fasted state
Measured: from predose up to 72 h post dosing
Part 2 Change from baseline in ECG parameters other than QT/QTc
QTcB, QRS, RR, PR intervals, U waves, T waves morphology
Measured: from predose up to Day 8
Part 2 Change from baseline in heart rate and blood pressure
Measured: from predose up to Day 8
Part 2 Incidence of QT/QTc changes from baseline greater than 30 and 60 ms post dose
Measured: from predose up to Day 8
Part 2 Incidence of QTc values greater than 450, 480 and 500 ms post dose
Measured: from predose up to Day 8
Part 2 Safety and tolerability of MIN-101 (adverse events occurrence, physical examination, safety laboratory tests)
Measured: from predose up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Crossover
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minerva Neurosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pui Leung, M.D, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232529
- Sponsor's protocol ID
- MIN-101C02
- Other IDs
- 2014-001613-53, 2014
- Status last verified
- Feb 2015
- First submitted
- 3 Sep 2014
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Study Designed to Evaluate the Pharmacokinetic Profile of MIN-101 and Its Main Metabolites Following Single and Multiple Dose Modified Release Prototype Formulation Administration in Healthy Cytochrome P450 2D6 Extensive Metabolizer Male and Female Subjects, and to Evaluate the Relationship Between the Pharmacokinetic Profile of MIN-101 and Its Main Metabolites and Cardiovascular Parameters.
- ClinicalTrials.gov ID
- NCT02232529
- Acronym / sponsor ID
- MIN-101C02
- Conditions
- Schizophrenia
- Keywords
- modified release formulation, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Minerva NeurosciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Sep 2014 (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.
The aim of the study is to assess how MIN-101 is taken up by the body when given in different amounts and in different formulations. The drug will be given as a single dose in Part 1 of the study and during Part 2 of the study as multiple dose, once daily for 7 days. The ultimate aim is to find an optimal formulation which can be developed as a once daily dose for the treatment of schizophrenia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: MIN-101 | Experimental | Drug: MIN-101MIN-101 modified release formulation (MR),single oral dose between 16 and 64 mg |
| Part 2: MIN-101 low dose | Experimental | Drug: MIN-101MIN-101 single daily oral dose, low dose MR formulation, from Day 1 to Day 7 |
| Part 2: placebo | Placebo comparator | Drug: Placeboplacebo MIN-101 daily oral dose from Day 1 to Day 7 |
| Part 2: MIN-101 high dose | Experimental | Drug: MIN-101MIN-101 single daily oral dose, low dose MR formulation, from Day 1 to Day 7 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males (Part 1 and Part 2) or non-pregnant, non-lactating healthy females (Part 2 only)
- Body mass index (BMI) of 18.0 to 30.0 kg/m2
- Must be CYP2D6 Extensive metabolizer
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
Key exclusion criteria (12 listed)
- Subjects who have QTc > 430 in male, > 450 in female confirmed by a repeat ECG
- Any family history of sudden cardiac death and Torsade de Points
- No personal or family history of unexplained presyncope, syncope or orthostatic hypotension
- History of any drug or alcohol abuse in the past 2 years
- History or evidence of any medically diagnosed clinically significant psychiatric disorders
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 | Part 1: MIN-101, Part 2: MIN-101 high dose, Part 2: MIN-101 low dose |
| Placebo | Drug | Part 2: placebo |
Primary outcome
Part 1 Pharmacokinetic profile of MIN-101 and its main metabolites (AUC (0-last), Tmax, Cmax, AUC (0-inf), %AUCextrap, Lambda z, T1/2 and parent:metabolites ratio
Time frame: predose and 0.5h, 1h, 1.5h, 2h, 2.5h, 3H, 4H, 6h, 8h, 10h, 12h, 14h, 16h, 20h, 24h, 48h and 72h post-dose
Part 2 - Pharmacokinetic profile of MIN-101 and its main metabolites - Absolute QT intervals and QT intervals corrected using Fridericia formula (QTcF)
Time frame: predose to Day 8
7 secondary outcomes
Part 1 Safety and tolerability (incidence of adverse events, safety laboratory, 12-lead ECGs, vital signs, physical examination) -
Time frame: from predose up to 72 h post dosing
Part 1 Pharmacokinetic profile of MIN-101 in fed and fasted state
Time frame: from predose up to 72 h post dosing
Part 2 Change from baseline in ECG parameters other than QT/QTc
Time frame: from predose up to Day 8
Part 2 Change from baseline in heart rate and blood pressure
Time frame: from predose up to Day 8
Part 2 Incidence of QT/QTc changes from baseline greater than 30 and 60 ms post dose
Time frame: from predose up to Day 8
Part 2 Incidence of QTc values greater than 450, 480 and 500 ms post dose
Time frame: from predose up to Day 8
Part 2 Safety and tolerability of MIN-101 (adverse events occurrence, physical examination, safety laboratory tests)
Time frame: from predose up to Day 8
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 24 Feb 2015.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Pui Leung, M.D principal investigator
Quotient Clinical
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 Schizophrenia, run by Minerva Neurosciences at 1 site in United Kingdom.
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 6 inclusion and 12 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 24 Feb 2015. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?
Part 1 Pharmacokinetic profile of MIN-101 and its main metabolites (AUC (0-last), Tmax, Cmax, AUC (0-inf), %AUCextrap, Lambda z, T1/2 and parent:metabolites ratio (time frame: predose and 0.5h, 1h, 1.5h, 2h, 2.5h, 3H, 4H, 6h, 8h, 10h, 12h, 14h, 16h, 20h, 24h, 48h and 72h post-dose). 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 24 Feb 2015.