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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01549106

Enrollment

106

Registered

2012-03-08

Start date

2011-08-31

Completion date

2012-02-29

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGIPI-145

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026