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CompletedNCT01925911DDIUpdated Mar 17, 2021

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

A Phase 1 interventional study of IPI-145 and Midazolam in Healthy, sponsored by SecuraBio. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-17.

Sponsored by SecuraBio · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Healthy

Keywords

  • Phase 1
  • Healthy subjects
  • DDI
  • CYP3A
03

In context

Lead sponsor

SecuraBio is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Interventions

  • DrugIPI-145

    25 mg BID Oral Capsule

  • DrugMidazolam

    2 mg midazolam syrup

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic parameters (AUC) of midazolam and 1-hydroxy-midazolam

    Time frame: Over 24 hours

  2. Pharmacokinetic parameters (Cmax) of midazolam and 1-hydroxy-midazolam

    Time frame: Over 24 hours

  3. Pharmacokinetic parameters (t1/2) of midazolam and 1-hydroxy-midazolam

    Time frame: Over 24 hours

  4. Plasma concentrations of midazolam and 1-hydroxy-midazolam

    Time frame: Over 24 hours

Secondary outcomes

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

    Safety Findings

    Time frame: 2 weeks

07

Study locations

1 site
  • PRA International
    Lenexa, Kansas 66219, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01925911
Lead sponsor
SecuraBio
Responsible party
Sponsor
First posted
Aug 20, 2013
Start date
Aug 2013
Primary completion
Sep 2013
Completion
Oct 2013
Last update
Mar 17, 2021

Study contacts

Hagop Youssoufian, MD
study chair · Verastem, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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