IPI-145 Single Ascending, Multiple Ascending, Food Effect and Drug-Drug-Interaction Study

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: IPI-145; Drug: Placebo

• Registration Number: NCT01549106
• Lead Sponsor: SecuraBio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-08
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

1. Gender : male or female
2. Age : 18-55 years, inclusive
3. Body Mass Index (BMI) : 18.0-30.0 kg/m2
4. Medical history without major pathology
5. 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
6. 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)
7. Willing and able to sign the written Informed Consent Form (ICF)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPI-145	IPI-145	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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	8 months
Plasma concentrations of IPI-145 and metabolites	8 months

Trial Locations

Locations (1)

PRA International; 🇳🇱 Zuidlaren, Netherlands