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A Study to Evaluate the DDI of HSK7653 With Metformin

Sponsor
Haisco Pharmaceutical Group Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT06084156
Collaborator
(none)
22
Enrollment
1
Location
1
Arm
4
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1, single center, open-label, single arm, drug-drug interaction study of HSK7653 and metformin in Healthy Subjects.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Clinical Study to Evaluate the Drug-Drug Interaction Between HSK7653 and Metformin in Healthy Subjects
Actual Study Start Date :
Aug 10, 2019
Actual Primary Completion Date :
Dec 9, 2019
Actual Study Completion Date :
Dec 9, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: HSK7653 and Metformin

Drug: HSK7653
Part 1: Day 1 to Day 4, not take; Part 2: Day 6 - Take HSK7653 35 mg; HSK7653 25 mg on day 13, day 20, day 27, and day 34; Part 3: Day 41 - Take HSK7653 25 mg

Drug: Metformin
Part 1: Day 1 to Day 4, 1000mg BID; Part 2: Not take; Part 3: Day 38- day 47, 1000mg BID

Outcome Measures

Primary Outcome Measures

  1. The primary pharmacokinetics parameter of Cmax To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects. [Day4, day 27 and day 41]

  2. The primary pharmacokinetics parameter of AUC To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects. [Day4, day 27 and day 41]

Secondary Outcome Measures

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [First dose of study drug up to 62 days after last dose of study drug]

  2. Pharmacodynamic responses of glucose, insulin and C-peptide will be evaluated [Day 41]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Age ≥18 and Age ≤60 years

  • BMI ≥18 and BMI ≤ 28 kg/m2 (Body Mass Index)

  • Able to understand the procedures of the study, and provide written informed consent and willing to comply with the study protocol procedures.

Exclusion Criteria:

  • Any finding of the medical examination (physical examination, laboratory examination, 12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical relevance during screening;

  • Fasting blood glucose <3.9mmol/L or ≥6.1mmol/L;

  • Has a condition affecting the absorption, distribution, metabolism, and excretion of the drug;

  • Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human immunodeficiency virus (HIV);

  • Treatment with an investigational drug within 3 months;

  • Other protocol-defined exclusion criteria.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Third Hospital Beijing Beijing China 100191

Sponsors and Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haisco Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier:
NCT06084156
Other Study ID Numbers:
  • HSK7653-102
First Posted:
Oct 16, 2023
Last Update Posted:
Oct 16, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Metformin

Study Results

No Results Posted as of Oct 16, 2023