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Pharmacokinetics and Metabolism of Radiolabeled BMS-690514 in Healthy Male Subjects

Pharmacokinetics and Metabolism of [14C] BMS-690514 in Healthy Male Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00578916
Enrollment
17
Registered
2007-12-21
Start date
2008-01-31
Completion date
2008-01-31
Last updated
2008-07-31

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

Conditions

Cancer

Brief summary

The purpose of this study is to determine how the human body processes and eliminates the drug (BMS-690514.

Interventions

DRUGEVRI (BMS-690514)

Oral Solution, Oral, 200 mg, single dose followed by 10-12 day inpatient stay

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy male subjects * Body mass index (BMS) of 18 - 30 kg/m², inclusive

Exclusion criteria

* Radiation exposure from diagnostic X-rays (except dental X-rays) in the last year or from clinical trials in the last 5 years

Design outcomes

Primary

MeasureTime frame
Single dose pharmacokinetics of BMS-690514 and radioactivity in plasma and urinemeasured for 10 days post-dose

Secondary

MeasureTime frame
Determination of biotransformation profiles and recorded adverse eventsfor 10 days post-dose

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026