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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549106
• Other study ID #: IPI-145-01
• Secondary ID: 2011-001944-31
• Status: Completed
• Phase: Phase 1
• Start date: August 2011
• Est. completion date: February 2012

Study information

• Verified date: March 2021
• Source: SecuraBio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• IPI-145
Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm; ketoconazole drug interaction study
• Placebo
Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm

Locations

Country	Name	City	State
Netherlands	PRA International	Zuidlaren

Sponsors (1)

Lead Sponsor	Collaborator
SecuraBio

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Plasma concentrations of IPI-145 and metabolites		8 months