NCT04899219CompletedPhase 1
An Open-label, Single-dose Study to Investigate the Pharmacokinetics of ACT-1014-6470 in Subjects With Severe Renal Impairment Compared to Control Subjects
Idorsia Pharmaceuticals Ltd.1 site in 1 country16 target enrollmentStarted: June 16, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Idorsia Pharmaceuticals Ltd.
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- PK of ACT-1014-6470 - Cmax
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Arms & Interventions
Group B (control subjects)
Experimental
Intervention: ACT-1014-6470 40 mg (Drug)
Group A (subjects with severe renal impairment)
Experimental
Intervention: ACT-1014-6470 40 mg (Drug)
Outcomes
Primary Outcomes
PK of ACT-1014-6470 - Cmax
Time Frame: Blood samples for PK analysis will be drawn at various time points (total duration: up to 6 days in Group A, up to 4 days in Group B).
For both Group A (subjects with severe renal impairment) and Group B (control subjects)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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