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

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 - BMS-986278 SAD MAD FE pH Japanese study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46573

Enrollment

Registered

2018-01-22

Start date

2018-02-06

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Idiopathic pulmonary fibrosis

Interventions

Part A: BMS-986278 or placebo will be given in the morning as a suspension with a volume between 6 mL and 50 mL. After administration of the study compound, the vial will be rinsed three times with

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of single and multiple ascending oral doses of BMS-986278 in healthy participants.	—

Secondary

Measure	Time frame
- To evaluate the plasma PK of single and multiple ascending oral doses of BMS-986278 in healthy participants. - To evaluate the effect of a high-fat meal and of a modified gastric pH on the plasma PK of a single dose of BMS-986278 in healthy participants.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)