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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT01947777
• Lead Sponsor: SecuraBio

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

Study Timeline

• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-20
• Study Start: 2013-10
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters (t1/2) of IPI-145 and its metabolite, IPI-656	Over 48 hours
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
Plasma concentrations of IPI-145 and its metabolite, IPI-656	Over 48 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

PRA International, Inc; 🇺🇸 Lenexa, Kansas, United States