COMPLETED

A Study to Assess the Effects of BPN14770 on Rosuvastatin

Conditions

Healthy Participants BPN14770 Rosuvastatin Pharmacokinetics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1, Open-label, 1-Sequence Crossover, Drug-drug Interaction Study to Assess the Effect of Repeated Doses of BPN14770 on the Pharmacokinetics of Rosuvastatin in Healthy Adult Participants

Quick Facts

Study Start:2025-07-18

Study Completion:2025-08-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT07011992

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Locations (Sites)

ICON Clinical Research

Lenexa, Kansas, 66219

United States

Collaborators and Investigators

Sponsor: Shionogi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-18

Study Completion Date2025-08-07

Study Record Updates

Study Start Date2025-07-18

Study Completion Date2025-08-07

Terms related to this study

Keywords Provided by Researchers

BPN14770
Rosuvastatin
Pharmacokinetics

Additional Relevant MeSH Terms

Healthy Participants