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Completed

NCT Number: NCT07531628

A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants

To assess pharmacokinetics, safety, and tolerability of multiple oral doses of verducatib in healthy Chinese male and female trial participants in order to facilitate the clinical development of verducatib in China.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, 310009, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male or female trial participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
  • Age of 18 to 55 years (inclusive)
  • BMI of 18.5 to 28 kg/m2 (inclusive)
  • Signed and dated written informed consent in accordance with International Council on Harmonization - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
  • Further inclusion criteria apply

Exclusion criteria

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 100 beats per minute (bpm)
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  • Further exclusion criteria apply

Treatment and study plan

Verducatib

Drug

Verducatib

Primary outcomes

  1. Area under the concentration-time curve of the analyte in plasma from time point 0 to time point 24 h after administration of the first dose (AUC0-24)

    Time frame: At 24 hours

  2. Maximum measured concentration of the analyte in plasma after administration of the first dose (Cmax)

    Time frame: At 24 hours

  3. Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)

    Time frame: Up to Day 64

  4. Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)

    Time frame: Up to Day 64

Secondary outcomes

  1. Occurrence of treatment emergent adverse events during the trial

    Time frame: Up to Day 65

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Pharmacokinetics, Safety, and Tolerability Study of Multiple Oral Doses of Verducatib for 4 Weeks in Healthy Chinese Male and Female Trial Participants (Open-label, Single Arm)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Sep 21, 2026

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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