A Study to Assess the Effects of BPN14770 on Rosuvastatin

Phase 1

Not yet recruiting

• Conditions: Healthy Participants
• Interventions: Drug: Rosuvastatin; Drug: BPN14770

• Registration Number: NCT07011992
• Lead Sponsor: Shionogi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-06-02
• Study First Posted: 2025-06-10
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-06-29
• Study Start: 2025-07-01
• Primary Completion: 2025-07-20
• Study Completion: 2025-07-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BPN14770	Rosuvastatin	Participants will receive rosuvastatin and BPN14770.
BPN14770	BPN14770	Participants will receive rosuvastatin and BPN14770.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of Rosuvastatin	Days 1 and 11 (pre-dose, up to 72 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin	Days 1 and 11 (pre-dose, up to 72 hours post-dose)

Secondary Outcome Measures

Name	Time	Method
Cmax of BPN14770	Day 11 (pre-dose, up to 72 hours post-dose)
Tmax of BPN14770	Day 11 (pre-dose, up to 72 hours post-dose)
Cmax of Coproporphyrin I	Days 1 and 11 (pre-dose, up to 72 hours post-dose)
Tmax of Coproporphyrin I	Days 1 and 11 (pre-dose, up to 72 hours post-dose)
Number of Participants Experiencing Treatment-emergent Adverse Events	Day 1 through Day 21