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

NCT04899219 | Completed Phase 1

• 1 other identifier: ID-087-104
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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).

Other Outcomes (3)

• PK of ACT-1014-6470 - Tmax

  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

  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

  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).

Study Arms (2)

Group A (subjects with severe renal impairment)

EXPERIMENTAL

Drug: ACT-1014-6470 40 mg

Group B (control subjects)

EXPERIMENTAL

Drug: ACT-1014-6470 40 mg

Interventions

ACT-1014-6470 40 mg DRUG

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

Group A (subjects with severe renal impairment); Group B (control subjects)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• \- 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).
• 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.

You may not qualify if:

• \- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

APEX GmbH

Munich, 81241, Germany

Location

MeSH Terms

Interventions

ACT-1014-6470

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, open-label, single-dose, parallel-group, Phase 1 study.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: June 16, 2021
• Primary Completion: November 12, 2021
• Study Completion: November 12, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)