Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-29 @ 5:29 AM
Study NCT ID:
NCT03072056
Status:
COMPLETED
Last Update Posted:
2017-08-31
First Post:
2017-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Study of MIN-101 and Its Metabolites in Healthy Subjects to Compare MIN-101 in Poor and Extensive Metabolizers
Sponsor:
Minerva Neurosciences
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* To evaluate the relationship between plasma levels of MIN-101 and changes in QT/QTcF intervals
* To evaluate safety and tolerability of MIN-101.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: