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

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 - IPI-145 ADME and absolute bioavailability study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38629

Enrollment

Registered

2013-02-20

Start date

2013-02-25

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

blood malignancies Inflammatory diseases

Interventions

Period 1: A single oral dose of 25 mg IPI-145 as a capsule, followed by a 15-minute IV infusion of 2.8 µg 14C-IPI-145 with a tracer amount of radioactivity (14.8 kBq). Period 2: A single oral dose o

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: blood and plasma concentrations of radioactivity, plasma concentrations of IPI-145, metabolite patterns in plasma, excretion of radioactivity, metabolite patterns in urine and feces, metabolite identity, absorption of IPI-145 Safety: adverse events, vital signs, ECG and clinical laboratory	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)