Phase 1 Study in Healthy Subjects to Evaluate the Effect... | NCT01925911

Studies
Phase 1 Study in Healthy Subjects to Evaluate the Effect of IPI-145 on the Pharmacokinetics of Midazolam

NCT01925911

Sponsor

SecuraBio

Status

Completed

Last Update Posted

Mar 17, 2021Actual

Enrollment

14Actual

Phase

Phase 1

Conditions

Healthy

Interventions

IPI-145
Midazolam

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Aug 15, 2013

First Submission Date that Met QC Criteria

Aug 16, 2013

First Posted Date

Aug 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2021

Last Update Posted Date

Mar 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the effect of IPI-145 on the pharmacokinetics of midazolam, a cytochrome P450 3A (CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with midazolam in healthy subjects.

Detailed Description

In Treatment Period 1, subjects will receive a single 2 mg oral dose of midazolam.
In Treatment Period 2, on Days 2-6, the same subjects will receive twice daily (BID) oral doses of 25 mg IPI-145; on Day 6, subjects will receive the morning dose of 25 mg IPI-145 concomitantly administered with 2 mg of midazolam.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IPI-145	Drug	25 mg BID Oral Capsule
Midazolam	Drug	2 mg midazolam syrup

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic parameters (AUC) of midazolam and 1-hydroxy-midazolam		Over 24 hours
Pharmacokinetic parameters (Cmax) of midazolam and 1-hydroxy-midazolam		Over 24 hours
Pharmacokinetic parameters (t1/2) of midazolam and 1-hydroxy-midazolam		Over 24 hours
Plasma concentrations of midazolam and 1-hydroxy-midazolam		Over 24 hours

Secondary Outcomes

Measure	Description	Time Frame
Incidence of adverse events following of administration midazolam, IPI-145 and the combination	Safety Findings	2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy men or women of non-childbearing potential between 18-50 years of age
Body Mass Index (BMI): 18.0 - 32.0 kg/m2.
In good health, determined by no clinically significant findings from clinical evaluations
Provided written informed consent prior to any study specific procedures

Exclusion Criteria:

Women of childbearing potential
Evidence of clinically significant medical conditions
History of gastrointestinal disease or surgery that may affect drug absorption
Positive or indeterminate tuberculosis-spot test at screening
Any active infection at the time of screening or admission
Subjects with acute narrow-angle glaucoma

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hagop Youssoufian, MD	Verastem, Inc.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PRA International		Lenexa	Kansas	66219	United States

Intervention Browse Module

MeSH Terms

ID	Term
C586691	duvelisib
D008874	Midazolam

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided