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Bioavailability of BMS-original molecule

Bioavailability of BMS-582949 Following Oral Administration of a 200 mg BMS-751324 (Pro-drug of BMS-582949) Tablet Relative to 2x100 mg BMS-751324 Capsules and to a 100 mg BMS-582949 Tablet, and the Effect of a High Fat Meal on the Bioavailability of BMS-582949 Following Oral Administration of a 200 mg BMS-751324 Tablet in Healthy Subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2008/091/000304
Enrollment
Unknown
Registered
2009-02-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: BMS Molecule: A: Single dose of 2 x 100 mg BMS-Pro-drug capsules B: Single dose of 200 mg BMS-Pro-drug tablet C: Single dose of 200 mg BMS-Pro-drug tablet D: Single dose of 100 mg BMS-

Sponsors

The Pharmaceutical Company Sponsoring This Study Is Bristol-Myers Squibb
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Signed Written Informed Consent a) The signed informed consent form. 2) Target Population a) Healthy subjects as determined by no clinically significant deviation from normal in medical history 3) Age and Sex Women who are not of childbearing potential

Exclusion criteria

Exclusion criteria: 1) Sex and Reproductive Status a) Women of child bearing potential 2) Medical History and Concurrent Diseases a) Any significant acute or chronic medical illness. 3) Physical and Laboratory Test Findings a) Evidence of organ dysfunction or any clinically significant deviation from normal, as determined by the Investigator, in physical examination, vital signs, ECG or clinical laboratory determinations prior to dosing. 4) Allergies and Adverse Drug Reactions

Design outcomes

Primary

MeasureTime frame
To assess the bioavailability of a high dose of BMS-pro-drug (of original molecule) tablet relative to half BID dosing of BMS-pro-drug (of original molecule) drug capsules.Timepoint: Four periods—

Secondary

MeasureTime frame
To assess the pharmacokinetics (PK) of BMS original molecule when BMS-pro-drug (of original molecule)tablet and BMS-original molecule tablet are administered. ? To assess the effect of a high fat meal (HFM) on the PKTimepoint:—

Countries

India

Contacts

Public ContactDr Manishkumar D Shah

MEDICAL DIRECTOR

manish.mistry@bms.com+91 22 66288600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026