A Study to Assess the Effects of BPN14770 on Rosuvastatin

Shionogi

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: BPN14770

Drug: Rosuvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT07011992

2413A4111

Details and patient eligibility

About

The primary objective of this study is to investigate the effects of BPN14770 on the pharmacokinetics of the breast cancer resistance protein and organic anion transporting polypeptide 1B1 substrate rosuvastatin in healthy adults.

Enrollment

12 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Overtly healthy as determined by medical evaluation including medical history, medical examination, laboratory tests, vital sign measurements, and 12-lead electrocardiogram at screening and on admission or participants whose laboratory values exceed the institutional reference range but deemed not clinically significant by the investigator in consideration of safety
Body mass index ≥18.5 and <32.0 kilograms/meter squared
All female participants must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations)

Key Exclusion Criteria:

Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (that is, increased intraocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment
Known history of allergic reaction to multiple medications and/or severe allergic reaction to any food or environmental allergens
Prior use of rosuvastatin that was discontinued for tolerability or adverse events
Received ≥4 types of investigational study interventions within 12 months prior to administration of study intervention
Positive drug or alcohol screen test result at screening or upon admission
Use of cannabis (medical or recreational), tobacco, or nicotine-containing products (including e-cigarettes, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission

Note: Other protocol-defined inclusion/exclusion criteria may apply