Back to resultsA Study to Investigate the Pharmacokinetics of ACT-1014-6470 in Subjects With Severe Renal Impairment Compared to Control Subjects
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
ACT-1014-6470 40 mg
Sponsored by
About this trial
This is an interventional other trial for Healthy
Eligibility Criteria
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.
Sites / Locations
- APEX GmbH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A (subjects with severe renal impairment)
Group B (control subjects)
Arm Description
Outcomes
Primary Outcome Measures
PK of ACT-1014-6470 - Cmax
For both Group A (subjects with severe renal impairment) and Group B (control subjects)
Secondary Outcome Measures
Full Information
NCT ID
NCT04899219
First Posted
May 19, 2021
Last Updated
November 26, 2021
Sponsor
Idorsia Pharmaceuticals Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04899219
Brief Title
A Study to Investigate the Pharmacokinetics of ACT-1014-6470 in Subjects With Severe Renal Impairment Compared to Control Subjects
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
November 12, 2021 (Actual)
Study Completion Date
November 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idorsia Pharmaceuticals Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, open-label, single-dose, parallel-group, Phase 1 study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (subjects with severe renal impairment)
Arm Type
Experimental
Arm Title
Group B (control subjects)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ACT-1014-6470 40 mg
Intervention Description
ACT-1014-6470 will be available as soft gelatin capsules for oral administration formulated at a dose strength of 20 mg.
Primary Outcome Measure Information:
Title
PK of ACT-1014-6470 - Cmax
Description
For both Group A (subjects with severe renal impairment) and Group B (control subjects)
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).
Other Pre-specified Outcome Measures:
Title
PK of ACT-1014-6470 - Tmax
Description
For both Group A (subjects with severe renal impairment) and Group B (control subjects)
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).
Title
Group B (control subjects): PK of ACT-1014-6470 - AUC0-inf
Description
For both Group A (subjects with severe renal impairment) and Group B (control subjects)
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).
Title
Group B (control subjects): PK of ACT-1014-6470 - T1/2
Description
For both Group A (subjects with severe renal impairment) and Group B (control subjects)
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
APEX GmbH
City
Munich
ZIP/Postal Code
81241
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Investigate the Pharmacokinetics of ACT-1014-6470 in Subjects With Severe Renal Impairment Compared to Control Subjects
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