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OpenTrials
Completed

NCT Number: NCT01925911

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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA International

Lenexa, Kansas, 66219, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IPI-145

Drug

25 mg BID Oral Capsule

midazolam

Drug

2 mg midazolam syrup

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

    Time frame: 2 weeks

    Safety Findings

Sponsors and collaborators

Lead sponsor

SecuraBio

Industry

Registry information

Official study title

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

Acronym: DDI

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 20, 2013
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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