IPI-145 ADME and Absolute Bioavailability Study

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836861
• Other study ID #: IPI-145-05
• Secondary ID: 2012-005425-75
• Status: Completed
• Phase: Phase 1
• Start date: March 2013
• Est. completion date: May 2013

Study information

• Verified date: March 2021
• Source: SecuraBio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME) and absolute bioavailability study in 6 healthy adult male subjects.

Description:

In Period 1, subjects will receive a single oral dose of 25 mg IPI-145, followed by a 15-minute IV infusion of approximately 2.8 μg 14C-IPI-145 containing 14.8 kBq of radioactivity.

In Period 2, the same subjects will receive a single dose of 25 mg 14C-IPI-145 as an oral suspension, containing approximately 3.15 MBq of radioactivity.

There will be a washout period of at least 14 days between Period 1 and Period 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Males, between 18 and 45 years of age, inclusive Body Mass Index (BMI) : 18.0-30.0 kg/m2

• In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs

• Provision of signed and dated, written informed consent prior to any study specific procedures

Exclusion Criteria:

• Evidence of clinically significant medical conditions

• History of gastrointestinal surgery that may affect drug absorption

• Positive or indeterminate QuantiFERON-TB Gold test at screening

• Any active infection at the time of screening or admission

• Participation in another ADME study with a radiation burden >0.1 mSv in the period of 1 year before screening

• Irregular defecation pattern (less than once per 2 days)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• IPI-145
Intravenous infusion: approximately 2.8 µg IPI-145 containing 14.8 kBq of radioactivity; Oral suspension: 25 mg IPI-145 containing approximately 3.15 MBq of radioactivity; Oral capsule: 25 mg IPI-145

Locations

Country	Name	City	State
Netherlands	Pharmaceuticals Research Association (PRA)	Zuidlaren

Sponsors (1)

Lead Sponsor	Collaborator
SecuraBio

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters (AUC) of IPI-145 in plasma		over 48 hours
Primary	PK parameters (AUC) and radioactivity excreted in urine and feces		over 144 hours
Primary	PK parameters (Cmax) of IPI-145 in plasma		over 48 hours
Primary	PK parameters (t1/2) of IPI-145 in plasma		over 48 hours
Primary	PK parameters (Cmax) and radioactivity excreted in urine and feces		over 144 hours
Primary	PK parameters (t1/2) and radioactivity excreted in urine and feces		over 144 hours
Secondary	Number of participants with adverse events following a single dose administration of IPI-145		over 4 weeks