Status:
COMPLETED
A Study to Investigate the Pharmacokinetics of ACT-1014-6470 in Subjects With Severe Renal Impairment Compared to Control Subjects
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
An open-label, single-dose study to investigate the pharmacokinetics of ACT-1014-6470 in subjects with severe renal impairment compared to control subjects
Eligibility Criteria
Inclusion
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- Male or female subject aged at least 18 years at Screening.
- Women of non-childbearing potential (e.g. post-menopausal)
- Additional inclusion criteria for subjects with severe renal impairment (Group A).
- \- Severe renal function impairment as confirmed at Screening based on an estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula of \< 30 mL/min (not on dialysis).
- Additional inclusion criteria for control subjects (Group B):
- Normal renal function as confirmed at Screening based on eGFR.
- Each control subject must be matched to the values of one subject with severe renal impairment based on age (±10 years difference allowed), BMI (±15% difference allowed), and sex, determined by results at Screening.
Exclusion
- \- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Key Trial Info
Start Date :
June 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04899219
Start Date
June 16 2021
End Date
November 12 2021
Last Update
November 29 2021
Active Locations (1)
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1
APEX GmbH
Munich, Germany, 81241