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

• Sponsor: SecuraBio (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01549106
• Collaborator: (none)
• Enrollment: 106
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 17.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: IPI-145; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• 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
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IPI-145	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 Comparator: Placebo	Drug: Placebo; Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm

Outcome Measures

Primary Outcome Measures

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 [8 months]

2. Plasma concentrations of IPI-145 and metabolites [8 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA International	Zuidlaren		Netherlands	9470 AE

Sponsors and Collaborators

• SecuraBio

Investigators

• Study Chair: Hagop Youssoufian, MD, Verastem, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SecuraBio
• ClinicalTrials.gov Identifier: NCT01549106
• Other Study ID Numbers: IPI-145-01; 2011-001944-31
• First Posted: Mar 8, 2012
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

Study Results

No Results Posted as of Mar 17, 2021