A Study to Test How Verducatib is Taken up in the Body of... | NCT07531628

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

NCT07531628

Sponsor

Boehringer Ingelheim

Status

Active, not recruiting

Last Update Posted

Jun 30, 2026Actual

Enrollment

9Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Verducatib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1111-1330-1379	Registry Identifier	WHO International Clinical Trials Registry Platform (ICTRP)

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2026Actual

Primary Completion Date

Aug 10, 2026Estimated

Completion Date

Oct 14, 2026Estimated

First Submitted Date

Apr 9, 2026

First Submission Date that Met QC Criteria

Apr 9, 2026

First Posted Date

Apr 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2026

Last Update Posted Date

Jun 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Label	Type	Description	Intervention Names
Verducatib treatment	Experimental		Drug: Verducatib

Name	Type	Description	Arm Group Labels	Other Names
Verducatib	Drug	Verducatib	Verducatib treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Occurrence of treatment emergent adverse events during the trial		Up to Day 65

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital Zhejiang University School of Medicine		Hangzhou		310009	China

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided