A Study to Investigate the Pharmacokinetics of ACT-1014-6470 in Subjects With Severe Renal Impairment Compared to Control Subjects
November 26, 2021 updated by: Idorsia Pharmaceuticals Ltd.
An Open-label, Single-dose Study to Investigate the Pharmacokinetics of ACT-1014-6470 in Subjects With Severe Renal Impairment Compared to Control Subjects
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 Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Munich, Germany, 81241
- Apex Gmbh
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A (subjects with severe renal impairment)
|
ACT-1014-6470 will be available as soft gelatin capsules for oral administration formulated at a dose strength of 20 mg.
|
|
Experimental: Group B (control subjects)
|
ACT-1014-6470 will be available as soft gelatin capsules for oral administration formulated at a dose strength of 20 mg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PK of ACT-1014-6470 - Tmax
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)
|
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).
|
|
Group B (control subjects): PK of ACT-1014-6470 - AUC0-inf
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)
|
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).
|
|
Group B (control subjects): PK of ACT-1014-6470 - T1/2
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)
|
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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 16, 2021
Primary Completion (Actual)
November 12, 2021
Study Completion (Actual)
November 12, 2021
Study Registration Dates
First Submitted
May 19, 2021
First Submitted That Met QC Criteria
May 19, 2021
First Posted (Actual)
May 24, 2021
Study Record Updates
Last Update Posted (Actual)
November 29, 2021
Last Update Submitted That Met QC Criteria
November 26, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID-087-104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.