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

Completed

• Conditions: 10027665; blood malignancies; inflammatory diseases; 10024324

• Registration Number: NL-OMON35436
• Lead Sponsor: Infinity Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 106

Inclusion Criteria

Age: 18 * 55 years, inclusive
BMI: 18.0 * 30.0 kg/m2, inclusive

Exclusion Criteria

Suffering from: hepatitis B, C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study or in case of donating more than 1.5 liter (for men)/ 1.0 liter (for women) of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and Tolerability</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics<br /><br>Pharmacodynamics</p><br>