A Pharmacokinetic Study of Modified Release (MR) Formulat... | NCT03038646

NCT03038646

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regimen A	Experimental	32 mg MIN-101 of the current modified-release formulation (comparator) identified as MR-32 formulation administered in the fasted state	Drug: MIN-101
Regimen B	Experimental	32 mg MIN-101 MR administered in the fasted state	Drug: MIN-101
Regimen C	Experimental	32 mg MIN-101 MR administered in the fasted state	Drug: MIN-101
Part 2 selected dose	Experimental	32 mg MIN-101 of MR administered in the fed state	Drug: MIN-101

Name	Type	Description	Arm Group Labels	Other Names
MIN-101	Drug		Part 2 selected dose Regimen A Regimen B Regimen C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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.
Part 1: Plasma PK parameter, Tmax		from predose up to 72 hours post dose
Part 1: Plasma PK parameter, Tlag		from predose up to 72 hours post dose
Part 1: Plasma PK parameter,partial AUC (e.g., AUC12, AUC24), AUClast, AUC∞		from predose up to 72 hours post dose
Part 1: Plasma PK parameter, λz and t1/2		from predose up to 72 hours post dose
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).	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.
Part 2: Plasma PK parameter, Tmax		from predose up to 72 hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Part 1: QTcF changes from baseline	The effect of coincidentally measured (time-matched) plasma concentrations of MIN-l0l on QTcF changes from Baseline.	from predose up to 72 hours post dose
Part 1: Safety (AE reporting, safety laboratory parameters analysis, vital signs and 12 lead ECG assessments)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
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.