A PHASE 1, OPEN-LABEL STUDY OF THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF 14C-LABELED IPI-145 AND THE ABSOLUTE BIOAVAILABILITY OF IPI-145 IN HEALTHY SUBJECTS

Completed

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

• Registration Number: NL-OMON38629
• 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: 6

Inclusion Criteria

Age: 18-45 years, inclusive
Gender: Male
BMI: 18.0-30.0 kg/m2

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>Pharmacokinetics: blood and plasma concentrations of radioactivity, plasma<br /><br>concentrations of IPI-145,<br /><br>metabolite patterns in plasma, excretion of radioactivity, metabolite patterns<br /><br>in urine and feces, metabolite identity,<br /><br>absorption of IPI-145<br /><br>Safety: adverse events, vital signs, ECG and clinical laboratory </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>