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

NCT07531628 | Not Yet Recruiting Phase 1

• 2 other identifiers: 1397-00271111-1330-1379
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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)

  At 24 hours

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

  At 24 hours

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

  Up to Day 64

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

  Up to Day 64

Secondary Outcomes (1)

• Occurrence of treatment emergent adverse events during the trial

  Up to Day 65

Study Arms (1)

Verducatib treatment

EXPERIMENTAL

Drug: Verducatib

Interventions

Verducatib DRUG

Verducatib

Verducatib treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, 310009, China

Location

Related Links

• Related Info

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

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: April 9, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): July 13, 2026
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): October 14, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)