Condition or disease | Intervention/treatment | Phase |
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Renal Insufficiency Healthy | Drug: ACT-541468 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Single-center, open-label, single-dose study |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Single-center, Open-label, Single-dose Study to Investigate the Pharmacokinetics of ACT-541468 in Subjects With Severe Renal Impairment Compared to Healthy Subjects |
Actual Study Start Date : | September 24, 2019 |
Actual Primary Completion Date : | August 14, 2020 |
Actual Study Completion Date : | August 14, 2020 |
Arm | Intervention/treatment |
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Experimental: Group A (healthy)
On Day 1, 8 healthy subjects will receive a single oral dose of 25 mg ACT-541468 in fasted condition.
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Drug: ACT-541468
ACT-541468 25 mg; administered orally
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Experimental: Group B (severe renal function impairment)
On Day 1, 8 subjects with severe renal function impairment will receive a single oral dose of 25 mg ACT-541468 in fasted condition.
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Drug: ACT-541468
ACT-541468 25 mg; administered orally
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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
General inclusion criteria for all subjects:
Additional inclusion criteria for healthy subjects (Group A):
Additional inclusion criteria for subjects with severe renal function impairment (Group B)
General exclusion criteria for all subjects:
Additional exclusion criteria for healthy subjects (Group A)
Additional exclusion criteria for subjects with severe renal function impairment (Group B).
- End-stage renal disease that requires dialysis.
Germany | |
APEX GmbH | |
München, Germany, 81241 |
Tracking Information | |||||
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First Submitted Date ICMJE | July 16, 2019 | ||||
First Posted Date ICMJE | July 18, 2019 | ||||
Last Update Posted Date | September 3, 2020 | ||||
Actual Study Start Date ICMJE | September 24, 2019 | ||||
Actual Primary Completion Date | August 14, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
AUC of ACT-541468 from time zero to 24 h after study drug administration (AUC0-inf) [ Time Frame: Blood samples for PK analysis will be taken at multiple time points after ACT-541468 administration for a total duration of up to 4 days ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Number of subjects with treatment-emergent (serious) adverse events (S)AEs [ Time Frame: During treatment with ACT-541468 administration for a total duration of up to 4 days ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects | ||||
Official Title ICMJE | A Single-center, Open-label, Single-dose Study to Investigate the Pharmacokinetics of ACT-541468 in Subjects With Severe Renal Impairment Compared to Healthy Subjects | ||||
Brief Summary | Study of the way the body takes up, distributes, and gets rid of ACT-541468 in subjects with abnormal kidney function compared to healthy subjects | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: Single-center, open-label, single-dose study Masking: None (Open Label)Primary Purpose: Other |
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Condition ICMJE |
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Intervention ICMJE | Drug: ACT-541468
ACT-541468 25 mg; administered orally
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
16 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | August 14, 2020 | ||||
Actual Primary Completion Date | August 14, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
General inclusion criteria for all subjects:
Additional inclusion criteria for healthy subjects (Group A):
Additional inclusion criteria for subjects with severe renal function impairment (Group B)
General exclusion criteria for all subjects:
Additional exclusion criteria for healthy subjects (Group A)
Additional exclusion criteria for subjects with severe renal function impairment (Group B). - End-stage renal disease that requires dialysis. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Germany | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04024332 | ||||
Other Study ID Numbers ICMJE | ID-078-115 2019-002159-40 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Idorsia Pharmaceuticals Ltd. | ||||
Study Sponsor ICMJE | Idorsia Pharmaceuticals Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Idorsia Pharmaceuticals Ltd. | ||||
Verification Date | September 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |