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MIN-101

Phase 1

Healthy Subjects | Small molecule | Other |Minerva Neurosciences, Inc|Last Updated: Aug 31, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03072056A Pharmacokinetic Study of MIN-101 and Its Metabolites in Healthy Subjects to Compare MIN-101 in Poor and Extensive MetabolizersPHASE1 COMPLETED 23 — — Jan 9, 2017Jul 7, 2017Aug 31, 20171 Ireland
NCT03038646A Pharmacokinetic Study of Modified Release (MR) Formulations of MIN-101 in Healthy SubjectsPHASE1 COMPLETED 14 — — Nov 30, 2016Apr 20, 2017Aug 31, 20171 Ireland
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Study Endpoints
Primary Endpoints
Plasma PK parameter, Cmax
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
from predose up to 76 hours post dose
Plasma PK parameter, Tlag
from predose up to 72 hours post dose
Plasma PK parameter,partial AUC (e.g., AUC12, AUC24), AUClast, AUC∞
from predose up to 72 hours post dose
Plasma PK parameter, λz and t1/2
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
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).
Part 1: Plasma PK parameter, Cmax
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.

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

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
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.

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).

Part 2: Plasma PK parameter, Tmax
from predose up to 72 hours post dose
Part 2: Plasma PK parameter, Tlag
from predose up to 72 hours post dose
Part 2: Plasma PK parameter, λz and t1/2
from predose up to 72 hours post dose
Secondary Endpoints
Safety (AE reporting, safety laboratory parameters analysis, vital signs and 12 lead ECG assessments)
3 months and 7 days
Part 1: 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)
2 months 16 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Extensive Metabolizers, 4 mgEXPERIMENTALsubjects will receive 32 mL of MIN-101 as a 0.125 mg/mL oral solution
Extensive Metabolizers, 8 mgEXPERIMENTALsubjects will receive 32 mL of MIN-101 as a 0.25 mg/mL oral solution
Extensive Metabolizers, 16 mgEXPERIMENTALsubjects will receive 32 mL of MIN-101 as a 0.5 mg/mL oral solution
Poor Metabolizers, 4 mgEXPERIMENTALsubjects will receive 32 mL of MIN-101 as a 0.125 mg/mL oral solution
Poor Metabolizers, 8 mgEXPERIMENTALsubjects will receive 32 mL of MIN-101 as a 0.25 mg/mL oral solution
Poor Metabolizers, 16 mgEXPERIMENTALsubjects will receive 32 mL of MIN-101 as a 0.5 mg/mL oral solution
Regimen AEXPERIMENTAL32 mg MIN-101 of the current modified-release formulation (comparator) identified as MR-32 formulation administered in the fasted state
Regimen BEXPERIMENTAL32 mg MIN-101 MR administered in the fasted state
Regimen CEXPERIMENTAL32 mg MIN-101 MR administered in the fasted state
Part 2 selected doseEXPERIMENTAL32 mg MIN-101 of MR administered in the fed state
Interventions
NameTypeDescription
MIN-101DRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Confirmed CYP2D6 extensive or poor metabolizer genotype 2. Subject has given voluntary written informed consent before performance of any study related procedure 3. Subject must be 18 to 45 years of age, inclusive 4. Subject must be a healthy male or female as indicated by th...

Countries:Ireland
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