A double-blind, placebo-controlled, randomized, single and multiple ascending dose study (including food effect, pH effect, and Japanese bridging Study) of the safety, pharmacokinetics, and exploratory pharmacodynamics of oral BMS-986278 administration in healthy participants

Completed

Conditions: Idiopathic pulmonary fibrosis
10010613

Registration Number: NL-OMON46573

Lead Sponsor: Bristol-Myers Squibb Research and Development

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 62

Inclusion Criteria

- healthy volunteers
- 21-65 yrs, inclusive, at screening
- BMI: 18.0-30.0 kg/m2, inclusive, at screening
- body weight: between 55 and 105 kg, inclusive, at screening

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study. Donation or loss of more than 100 mL of blood within 2 months prior to (the first) drug administration. Donation or loss of more than 1.5 L of blood (for male participants)/more than 1.0 L of blood (for female participants) in the 10 months prior to (the first) drug administration in the current study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the safety and tolerability of single and multiple ascending oral<br /><br>doses of BMS-986278 in healthy participants.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To evaluate the plasma PK of single and multiple ascending oral doses of<br /><br>BMS-986278 in healthy participants.<br /><br>- To evaluate the effect of a high-fat meal and of a modified gastric pH on the<br /><br>plasma PK of a single dose of BMS-986278 in healthy participants.</p><br>

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Stay informed of key developments in this trial with timely notifications for researchers and healthcare professionals.

Enrollment status and site changes

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Outcome data and publication updates

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A double-blind, placebo-controlled, randomized, single and multiple ascending dose study (including food effect, pH effect, and Japanese bridging Study) of the safety, pharmacokinetics, and exploratory pharmacodynamics of oral BMS-986278 administration in healthy participants

Recruitment & Eligibility

Study & Design

Related Research Topics

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Clinical Trial Alerts

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