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An open-label, single-sequence study to investigate the effects of gastric acid suppression by Rabeprazole on the pharmacokinetics of BMS-986165 in healthy participants

An open-label, single-sequence study to investigate the effects of gastric acid suppression by Rabeprazole on the pharmacokinetics of BMS-986165 in healthy participants - Gastric pH effect on BMS-986165

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47975
Enrollment
20
Registered
2019-04-24
Start date
2019-05-22
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Psoriasis systemic lupus erythematosus and Crohn's disease.

Interventions

BMS-986165 and rabeprazole will be given as oral tablets with 240 milliliters (mL) of water. During the first 4 hours after administration of the study compound the volunteer will not be allowed t

Sponsors

BritsolMyers Squibb Research and Development
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy male and female subjects - Age of 18 to 50 years (inclusive) - BMI of 18.0 to 32.0 kg/m2 (inclusive)

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only). Blood transfusion within 4 weeks of study drug administration.

Design outcomes

Primary

MeasureTime frame
PK parameters in healthy participants administered BMS-986165 alone (reference) versus in combination with rabeprazole (test): - BMS-986165: Cmax, AUC(0-T), AUC(INF)

Secondary

MeasureTime frame
PK of BMS-986165 administered alone (reference) versus in combination with rabeprazole (test) - BMS-986165: Tmax, T-Half - Total active circulating species: Cmax, AUC(0-T), AUC(INF)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)