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Healthy SubjectsPhase 1NCT03038646

A Pharmacokinetic Study of Modified Release (MR) Formulations of MIN-101 in Healthy Subjects

A Phase 1 study testing MIN-101 in people with Healthy Subjects, run by Minerva Neurosciences at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the pharmacokinetic (PK) profiles of MIN-l0l following administration of modified release (MR) formulations of MIN-l0l in healthy male and female subjects To select 1 MR formulation for use in fed state To evaluate the effect of food on the bioavailability of MIN-l0l selected MR formulation Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
MIN-101
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteIreland
Study dates
30 Nov 2016to 20 Apr 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 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Confirmed CYP 2D6 extensive metaboliser genotype
  • Subject has given voluntary written informed consent before performance of any study related procedure
  • Must be 18 to 45 years of age, inclusive
  • Subject must be a healthy male or female as indicated by the protocol
  • Agree to abstain from all medication (except for allowed birth control for 21 days before the first dose with MIN-101
  • Subject agrees to use the methods of birth control as outlined in the protocol
  • Must be willing and able to communicate and participate in the whole study.
  • Willing to eat all the food supplied throughout the study.

Who cannot join

  • A history of clinically significant gastrointestinal disease, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic or psychiatric 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 diarrhoea or constipation in the 7 days before the predicted 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 = 1/2 pint beer, 25 mL of 40or a 125 mL glass of wine)
  • Subject has a borderline or long QTc Fridericia interval 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 who are pregnant or breast feeding
  • Subject has used any prescription medication or over-the-counter (OTC) medication, including vitamin supplements, within 21 days prior to day l
  • Subject has been treated with any known P450 206 or 3A4 enzymes altering drugs within 30 days prior to the study
  • Subject has smoked or used nicotine products within 2 months prior to or during the study
  • Subject has sought advice from or been referred to a GP or counsellor 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
  • Any current or previous use of drugs such as opiates, cocaine, ecstasy, or intravenous amphetamines and/or a positive urine screen for alcohol or drugs of abuse. 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 a current uncontrolled inter-current illness (i.e., active infection) or has had a clinically significant illness within the last 30 days prior to Day 1
  • Subject has had major surgery within 28 days of study entry, or 12 months prior to study for gastrointestinal surgery.
  • Failure to satisfy the investigator of fitness to participate for any other reason.

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • Biokinetic Europe

    Belfast, BT2 7BA

Other trials in Ireland

About this study

Official title: A Phase 1, Open-Label, Randomised, 3-Treatment, 3-Period, Single-Dose, Crossover Study in Healthy Subjects to Compare the Pharmacokinetic Properties of Modified Release (MR) Formulations of MIN-101 Followed by Food Effect Testing of a Selected Formulation

  • To evaluate the pharmacokinetic (PK) profiles of MIN-l0l following administration of modified release (MR) formulations of MIN-l0l in healthy male and female subjects
  • To select 1 MR formulation for use in fed state
  • To evaluate the effect of food on the bioavailability of MIN-l0l selected MR formulation
Being tested
MIN-101
Keywords
Pharmacokinetics, Food Effect

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MIN-101Drug

Study groups in NCT03038646
Study groupRoleWhat they receive
Regimen AExperimental32 mg MIN-101 of the current modified-release formulation (comparator) identified as MR-32 formulation administered in the fasted state
Receives: Drug: MIN-101
Regimen BExperimental32 mg MIN-101 MR administered in the fasted state
Receives: Drug: MIN-101
Regimen CExperimental32 mg MIN-101 MR administered in the fasted state
Receives: Drug: MIN-101
Part 2 selected doseExperimental32 mg MIN-101 of MR administered in the fed state
Receives: Drug: MIN-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: 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: from predose up to 72 hours post dose: Blood samples for MIN-101 will be collected at time 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, and 72 hours post-dose on Day 1 of all periods.

  2. Part 1: Plasma PK parameter, Tmax

    Measured: from predose up to 72 hours post dose

  3. Part 1: Plasma PK parameter, Tlag

    Measured: from predose up to 72 hours post dose

  4. Part 1: Plasma PK parameter,partial AUC (e.g., AUC12, AUC24), AUClast, AUC∞

    Measured: from predose up to 72 hours post dose

  5. Part 1: Plasma PK parameter, λz and t1/2

    Measured: from predose up to 72 hours post dose

  6. Part 2: Plasma PK parameter, Cmax

    To estimate the relative bioavailability of MIN-101 and its main metabolites following the administration of the selected modified release formulation in different food conditions (fasted or fed state).

    Measured: from predose up to 72 hours post dose: Blood samples for MIN-101 will be collected at time 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, and 72 hours post-dose on Day 1 of all periods.

  7. Part 2: Plasma PK parameter, Tmax

    Measured: from predose up to 72 hours post dose

  8. Part 2: Plasma PK parameter, Tlag

    Measured: from predose up to 72 hours post dose

  9. Part 2: Plasma PK parameter, λz and t1/2

    Measured: from predose up to 72 hours post dose

Secondary outcomes (3)

  1. Part 1: QTcF changes from baseline

    The effect of coincidentally measured (time-matched) plasma concentrations of MIN-l0l on QTcF changes from Baseline.

    Measured: from predose up to 72 hours post dose

  2. Part 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: 2 months 16 days

  3. Part 2: 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: 2 months 16 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2017 (estimated)
  2. Study start30 Nov 2016
  3. Primary completion20 Apr 2017
  4. Study completion20 Apr 2017

Resources

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
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03038646
Sponsor's protocol ID
MIN-101C06
Status last verified
Aug 2017
First submitted
10 Jan 2017
Last updated
31 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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 8 inclusion and 16 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?

Part 1: Plasma PK parameter, Cmax (time frame: from predose up to 72 hours post dose: Blood samples for MIN-101 will be collected at time 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, and 72 hours post-dose on Day 1 of all periods.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03038646.

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.

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