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

A Phase 1, Open-Label, Single-Sequence, 2-Period Study to Evaluate the Effect of IPI-145 on Single-Dose Pharmacokinetics of Midazolam (a CYP3A Substrate) in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01925911

Acronym

DDI

Enrollment

Registered

2013-08-20

Start date

2013-08-31

Completion date

2013-10-31

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase 1, Healthy subjects, DDI, CYP3A

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.

Interventions

DRUGIPI-145

25 mg BID Oral Capsule

DRUGMidazolam

2 mg midazolam syrup

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

* 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

Design outcomes

Primary

Measure	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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026