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Completed

NCT Number: NCT01947777

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

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA International, Inc

Lenexa, Kansas, 66219, United States

About this study

  • In Treatment Period 1, subjects will receive a single 25 mg oral dose of IPI-145
  • In Treatment Period 2, on Days 3-9, the same subjects will receive once daily (QD) oral doses of 600 mg rifampin; on Day 9, subjects will receive a single oral dose of 25 mg IPI-145 concomitantly administered with 600 mg of rifampin

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
  • Consumption of any nutrients known to modulate cytochrome P450 enzyme activity within 14 days prior to administration of study drug, during the study, and until after discharge

Treatment and study plan

IPI-145

Drug

25 mg oral capsule

Rifampin

Drug

2x 300 mg oral capsule

Primary outcomes

  1. Pharmacokinetic parameters (AUC) of IPI-145 and its metabolite, IPI-656

    Time frame: Over 48 hours

  2. Pharmacokinetic parameters (Cmax) of IPI-145 and its metabolite, IPI-656

    Time frame: Over 48 hours

  3. Pharmacokinetic parameters (t1/2) of IPI-145 and its metabolite, IPI-656

    Time frame: Over 48 hours

  4. Plasma concentrations of IPI-145 and its metabolite, IPI-656

    Time frame: Over 48 hours

Secondary outcomes

  1. Incidence of adverse events following administration of IPI-145, rifampin, 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 Rifampin (a CYP3A Inducer) on the Pharmacokinetics of IPI-145 in Healthy Subjects

Acronym: DDI

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 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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