NCT01925911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

August 15, 2013

Last Update Submit

March 15, 2021

Conditions

Healthy

Keywords

Phase 1Healthy subjectsDDICYP3A

Outcome Measures

Primary Outcomes (4)

  • 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 (1)

  • Incidence of adverse events following of administration midazolam, IPI-145 and the combination

    2 weeks

Interventions

IPI-145DRUG

25 mg BID Oral Capsule

MidazolamDRUG

2 mg midazolam syrup

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA International

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

duvelisibMidazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Hagop Youssoufian, MD

    Verastem, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2013

First Posted

August 20, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

US(1)