IPI-145 ADME and Absolute Bioavailability Study
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
2 other identifiers
interventional
6
1 country
1
Brief Summary
This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME) and absolute bioavailability study in 6 healthy adult male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Mar 2013
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 22, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMarch 17, 2021
March 1, 2021
1 month
April 1, 2013
March 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
PK parameters (AUC) of IPI-145 in plasma
over 48 hours
PK parameters (AUC) and radioactivity excreted in urine and feces
over 144 hours
PK parameters (Cmax) of IPI-145 in plasma
over 48 hours
PK parameters (t1/2) of IPI-145 in plasma
over 48 hours
PK parameters (Cmax) and radioactivity excreted in urine and feces
over 144 hours
PK parameters (t1/2) and radioactivity excreted in urine and feces
over 144 hours
Secondary Outcomes (1)
Number of participants with adverse events following a single dose administration of IPI-145
over 4 weeks
Study Arms (1)
IPI-145 and [14C] IPI-145
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SecuraBiolead
Study Sites (1)
Pharmaceuticals Research Association (PRA)
Zuidlaren, Netherlands
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Hagop Youssoufian, MD
Verastem, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2013
First Posted
April 22, 2013
Study Start
March 1, 2013
Primary Completion
April 1, 2013
Study Completion
May 1, 2013
Last Updated
March 17, 2021
Record last verified: 2021-03