A Study to Assess the Effects of BPN14770 on Rosuvastatin

NCT07011992 | Completed Phase 1 FDA Drug

• 1 other identifier: 2413A4111
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

BPN14770; Rosuvastatin; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

BPN14770

EXPERIMENTAL

Participants will receive rosuvastatin and BPN14770.

Drug: Rosuvastatin; Drug: BPN14770

Interventions

Rosuvastatin DRUG

Oral tablet

BPN14770

BPN14770 DRUG

Oral capsule

Also known as: Zatolmilast

BPN14770

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shionogi: lead

Study Sites (1)

ICON Clinical Research

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

Rosuvastatin Calcium; BPN14770

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: July 18, 2025
• Primary Completion: July 31, 2025
• Study Completion: August 7, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)