Clinical Trials Logo
  1. Home
  2. Cancer
  3. NCT00578916
  4. Details
NCT00578916 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00578916
Other study ID # CA187-003
Secondary ID
Status Completed
Phase Phase 1
First received December 19, 2007
Last updated July 30, 2008
Start date January 2008
Est. completion date January 2008

Study information
Verified date July 2008
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority Switzerland: SwissmedicSwitzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• EVRI (BMS-690514)
Oral Solution, Oral, 200 mg, single dose followed by 10-12 day inpatient stay

Locations
Country Name City State
Switzerland Local Institution Allschwil

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Single dose pharmacokinetics of BMS-690514 and radioactivity in plasma and urine measured for 10 days post-dose No
Secondary Determination of biotransformation profiles and recorded adverse events for 10 days post-dose No
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients

External Links