A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food and Ketoconazole on the Pharmacokinetics of IPI-145 When Administered to Healthy Adult Subjects

SecuraBio1 site in 1 country106 target enrollmentAugust 2011

ConditionsHealthy Volunteers

InterventionsIPI-145 Placebo

DrugsIPI-145 Placebo

Overview

Phase: Phase 1
Intervention: IPI-145
Conditions: Healthy Volunteers
Sponsor: SecuraBio
Enrollment: 106
Locations: 1
Primary Endpoint: Safety and tolerability assessments consisting of adverse events, vital signs, 12-lead ECG, clinical laboratory tests and physical examinations will be performed following IPI-145 single and repeat oral administration in healthy subjects
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-145 after single and repeat oral administration, and to evaluate the effects of food and ketoconazole on the plasma pharmacokinetics of IPI-145.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

February 2012

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

SecuraBio

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Gender : male or female
•Age : 18-55 years, inclusive
•Body Mass Index (BMI) : 18.0-30.0 kg/m2
•Medical history without major pathology
•For males only: Willingness to use adequate contraception from the time of dosing and not donate sperm until 3 months after the follow-up visit
•Females who have a negative pregnancy test at screening and on each admission, and are of non-childbearing potential. Females of non-childbearing potential are defined as women who are surgically sterile or post-menopausal (defined as at least 1 year post cessation of menses and follicular stimulating hormone (FSH) \>23.0 mIU/mL)
•Willing and able to sign the written Informed Consent Form (ICF)

Exclusion Criteria

•Previous participation in the current study
•Evidence of clinically relevant pathology
•History of relevant drug and/or food allergies
•Part 4 only: Known or suspected adverse reaction or contraindication to the imidazole class of drugs

Arms & Interventions

IPI-145

Intervention: IPI-145

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Safety and tolerability assessments consisting of adverse events, vital signs, 12-lead ECG, clinical laboratory tests and physical examinations will be performed following IPI-145 single and repeat oral administration in healthy subjects

Time Frame: 8 months

Plasma concentrations of IPI-145 and metabolites

Time Frame: 8 months