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Completed

NCT Number: NCT07011992

A Study to Assess the Effects of BPN14770 on Rosuvastatin

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Clinical Research

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

Oral tablet

BPN14770

Drug

Oral capsule

Other names: Zatolmilast

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of Rosuvastatin

    Time frame: Days 1 and 11 (pre-dose, up to 72 hours post-dose)

  2. Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin

    Time frame: Days 1 and 11 (pre-dose, up to 72 hours post-dose)

Secondary outcomes

  1. Cmax of BPN14770

    Time frame: Day 11 (pre-dose, up to 72 hours post-dose)

  2. Tmax of BPN14770

    Time frame: Day 11 (pre-dose, up to 72 hours post-dose)

  3. Cmax of Coproporphyrin I

    Time frame: Days 1 and 11 (pre-dose, up to 72 hours post-dose)

  4. Tmax of Coproporphyrin I

    Time frame: Days 1 and 11 (pre-dose, up to 72 hours post-dose)

  5. Number of Participants Experiencing Treatment-emergent Adverse Events

    Time frame: Day 1 through Day 21

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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