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

NCT04024332 | Completed Phase 1

• 2 other identifiers: ID-078-1152019-002159-40
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Insufficiency; Healthy

Outcome Measures

Primary Outcomes (1)

• AUC of ACT-541468 from time zero to 24 h after study drug administration (AUC0-inf)

  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

Secondary Outcomes (1)

• Number of subjects with treatment-emergent (serious) adverse events (S)AEs

  During treatment with ACT-541468 administration for a total duration of up to 4 days

Other Outcomes (4)

• Maximum plasma concentration (Cmax) of ACT-541468

  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

• Time to reach maximum plasma concentration (tmax) of ACT-541468

  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

• Terminal half-life (t½) of ACT-541468

  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

Study Arms (2)

Group A (healthy)

EXPERIMENTAL

On Day 1, 8 healthy subjects will receive a single oral dose of 25 mg ACT-541468 in fasted condition.

Drug: ACT-541468

Group B (severe renal function impairment)

EXPERIMENTAL

On Day 1, 8 subjects with severe renal function impairment will receive a single oral dose of 25 mg ACT-541468 in fasted condition.

Drug: ACT-541468

Interventions

ACT-541468 DRUG

ACT-541468 25 mg; administered orally

Group A (healthy); Group B (severe renal function impairment)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent in the local language prior to any study mandated procedure.
• Male and female subjects aged 18 to 85 years (inclusive) at screening.
• Body mass index (BMI) from 18 to 35 kg/m2 (inclusive) at screening. Body weight at least 50 kg.
• Women of childbearing potential: Women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use (during the entire study and 30 days thereafter) a highly effective method of contraception with a failure rate of \< 1% per year.
• Women of non-childbearing potential, i.e., postmenopausal, XY genotype, Turner syndrome, uterine agenesis: no contraceptive requirement.
• Normal renal function as confirmed based on Creatinine Clearance (CLcr) by the Cockcroft-Gault equation adjusted for age: \>= 80 mL/min for subjects \<= 50 years of age; \>= 70 mL/min for subjects 51-60 years of age; \>= 60 mL/min for subjects 61-85 years of age; CLcr = (\[140-age(years)\]×weight (kg))/(72×serum creatinine (mg/dL)) (x 0.85 for female subjects)
• The CLcr value should be confirmed (± 25%) on Day -1 in case subjects will be dosed more than 10 days after the day of screening.
• Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
• Each healthy subject must be matched with one subject with severe renal function impairment with regard to age (± 10 years difference allowed), body weight (± 15% difference allowed), and sex, determined by results at screening.
• Severe renal function impairment as confirmed based on CLcr by the Cockcroft-Gault equation: \<30 mL/min, not on dialysis.
• The CLcr value should be confirmed (± 25%) on Day -1 since subjects will be dosed more than 10 days after the day of screening.
• Hematology, clinical chemistry, coagulation and urinalysis test results consistent with severe renal function impairment at screening.
• Physical examination without clinically relevant abnormalities at screening and on Day -1 (except for those related to severe renal function impairment), which would interfere with the objectives of the study.
• Stable concomitant medications.

You may not qualify if:

• Pregnant or lactating women.
• Clinically relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal
• History of renal and/or liver transplant.
• Hepatic cancer, primary biliary cirrhosis or any form of cholestatic disease.
• Use of drugs which might interfere with the PK of ACT-541468 (moderate to strong CYP3A4 inhibitors or inducers).
• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
• History or clinical evidence of any unstable disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy, herniotomy, and cholecystectomy allowed).
• Intake of any creatine supplement from screening to EOS.
• \- End-stage renal disease that requires dialysis.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

APEX GmbH

München, 81241, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

daridorexant

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

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: Single-center, open-label, single-dose study

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: September 24, 2019
• Primary Completion: August 14, 2020
• Study Completion: August 14, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)