Phase 1 PK Study to Assess Safety, PK, Tolerability of HM15912 in Subjects With Renal Impairment and Normal Renal Function

Renal Impairment Clinical Trial

Official title:

An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects With Renal Impairment and Matched Control Subjects With Normal Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05711381
• Other study ID #: HM-GLP2-102
• Status: Completed
• Phase: Phase 1
• Start date: December 2, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: December 2023
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects with Renal Impairment and Matched Control Subjects with Normal Renal Function

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject voluntairly agrees to participate in this study and sign an IRB-approved informed consent prior to perfomring any of the Screening visit procedures

• Males and females = 18 and = 80 years of age at the Screening visit

• Body mass index of = 17.5 and = 40.0 kg/m2

• Meet the following eGFR criteria during the screening period based on the CKD-EPI equation: Severe renal imapriment: eGFR < 30 mL/min/1.73m2 but not requiring hemodialysis. Moderate renal impairment: 30 mL/min/1.73m2 = eGFR < 60 mL/min/1.73m2, Normal renal function (eGFR = 90 mL/min/1.73m2)

Exclusion Criteria:

• Renal transplant recipients or subjects requiring hemodialysis and peritoneal dialysis

• Subjects with a history or presence of any psychiatric disoerder that, in the opion of the investigator, might confound the results of the study or pose addiitonal risk in administering the IP to the subject

• Evidence of any viral (including COVID-19), bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to the Screening visit

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• HM15912
Drug: HM15912 Active 0.5mg/kg

Locations

Country	Name	City	State
United States	AMR Knoxville	Knoxville	Tennessee
United States	Clinical Pharmacology of Miami	Miami	Florida
United States	Panax Clinical Research	Miami Lakes	Florida
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum serum concentration (Cmax)		Day 1 to 29 (Total duration: 29 days)
Primary	Area under the concentration-time curve from extrapolated to infinity (AUC 0-infinity)		Day 1 to 29 (Total duration: 29 days)