Skip to main content
OpenTrials
Completed

NCT Number: NCT01549106

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA International

Zuidlaren, 9470 AE, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IPI-145

Drug

Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm; ketoconazole drug interaction study

Placebo

Drug

Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm

Primary outcomes

  1. 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

  2. Plasma concentrations of IPI-145 and metabolites

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

SecuraBio

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2012
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.