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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01947777

Acronym

DDI

Enrollment

Registered

2013-09-20

Start date

2013-10-31

Completion date

2013-12-31

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 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

Detailed description

* 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

Interventions

DRUGIPI-145

25 mg oral capsule

DRUGRifampin

2x 300 mg oral capsule

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 * 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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters (AUC) of IPI-145 and its metabolite, IPI-656	Over 48 hours
Pharmacokinetic parameters (Cmax) of IPI-145 and its metabolite, IPI-656	Over 48 hours
Pharmacokinetic parameters (t1/2) of IPI-145 and its metabolite, IPI-656	Over 48 hours
Plasma concentrations of IPI-145 and its metabolite, IPI-656	Over 48 hours

Secondary

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

Countries

United States

Outcome results

None listed

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