A Study to Investigate the Pharmacokinetics of ACT-1014-6470 in Subjects With Severe Renal Impairment Compared to Control Subjects

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04899219
• Other study ID #: ID-087-104
• Status: Completed
• Phase: Phase 1
• Start date: June 16, 2021
• Est. completion date: November 12, 2021

Study information

• Verified date: November 2021
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 12, 2021
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Renal Insufficiency

Intervention

Drug:
• ACT-1014-6470 40 mg
ACT-1014-6470 will be available as soft gelatin capsules for oral administration formulated at a dose strength of 20 mg.

Locations

Country	Name	City	State
Germany	APEX GmbH	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PK of ACT-1014-6470 - Tmax	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	Group B (control subjects): PK of ACT-1014-6470 - AUC0-inf	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	Group B (control subjects): PK of ACT-1014-6470 - T1/2	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).
Primary	PK of ACT-1014-6470 - Cmax	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).