Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03913000
Other study ID # ID-085-103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 29, 2019
Est. completion date August 22, 2019

Study information

Verified date November 2019
Source Idorsia Pharmaceuticals Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the pharmacokinetics (PK), tolerabilty and safety of a single dose of ID-085 in subjects with mild, moderate, and severe renal function impairment compared to healthy subjects


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date August 22, 2019
Est. primary completion date August 22, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 79 Years
Eligibility Inclusion Criteria:

All subjects:

- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.

- Male and female subjects aged between 18 and 79 years (inclusive) at screening.

- Body mass index (BMI) of 18.0 to 34.0 kg/m2 (inclusive) at screening. Body weight of at least 50 kg.

- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day-1. They must consistently and correctly use (from at least first dosing, during the entire study, and for at least 30 days after last study treatment intake) a highly effective method of contraception with a failure rate of < 1% per year and must use condoms, diaphragm or cervical cap with spermicide, or be sexually abstinent. Hormonal contraceptive must be initiated at least 1 month before study treatment administration.

Renal function impairment subjects:

• At screening and on Day -1, the stage of renal function impairment will be defined by Creatinine Clearance (CLcr) by the Cockcroft-Gault (C-G) equation:

- Mild renal function impairment: CLcr 60-89 mL/min (Group A).

- Moderate renal function impairment: CLcr 30-59 mL/min (Group B).

- Severe renal function impairment: CLcr <30 mL/min (Group C).

The stage of renal impairment will need to be confirmed at Day -1 and the CLcr values on Day -1 will need to remain within ± 25% of the screening value.

Healthy subjects:

• Normal renal function confirmed by a CLcr = 90 mL/min. Normal renal function will need to be confirmed at Day -1 and the CLcr value on Day -1 will need to remain within ± 25% of the screening value.

Exclusion Criteria:

All subjects:

- Pregnant or lactating women.

- Known hypersensitivity to ID-085 or treatments of the same class, or any of its excipients.

- Known hypersensitivity or allergy to natural rubber latex.

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

Renal function impairment subjects:

- Subjects on dialysis.

- Hemoglobin concentration < 9 g/dL.

- Serum potassium concentration > 6 mmol/L.

- Platelet count < 100 × 10^6/mL.

- History of severe renal stenosis.

- History of clinically relevant bleeding disorder.

- Gastrointestinal bleeding within 2 weeks prior to screening.

- Presence of unstable diabetes mellitus.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ID-085
Hard capsules for oral administration formulated at a strength of 200 mg

Locations

Country Name City State
Germany CRS Clinical Research Services Kiel GmbH Kiel

Sponsors (1)

Lead Sponsor Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t) Will be derived by non-compartmental analysis of the plasma concentration-time profiles Up to Day 3 after treatment administration
Primary The plasma AUC from zero to infinity (AUC0-inf), calculated with the apparent ?z Will be derived by non-compartmental analysis of the plasma concentration-time profiles Up to Day 3 after treatment administration
Primary The maximum plasma concentration (Cmax) Will be derived by non-compartmental analysis of the plasma concentration-time profiles Up to Day 3 after treatment administration
Primary The time to reach Cmax (tmax) Will be derived by non-compartmental analysis of the plasma concentration-time profiles Up to Day 3 after treatment administration
Primary Apparent total body clearance (CL/F) Will be derived by non-compartmental analysis of the plasma concentration-time profiles Up to Day 3 after treatment administration
Primary Apparent volume of distribution (Vz/F) Will be derived by non-compartmental analysis of the plasma concentration-time profiles Up to Day 3 after treatment administration
See also
  Status Clinical Trial Phase
Completed NCT01937975 - The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050) Phase 1
Completed NCT03284164 - Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex Phase 1
Completed NCT05992155 - A Study of TAK-279 in Adults With or Without Kidney Problems Phase 1
Completed NCT05004311 - The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics Phase 1
Completed NCT04963738 - A Study of JNJ-73763989 in Adult Participants With Renal Impairment Phase 1
Terminated NCT02508740 - Single Oral Dose of Bevenopran in Patients With Varying Degrees of Renal Impairment Phase 1
Active, not recruiting NCT01529658 - Renal Hypothermia During Partial Nephrectomy N/A
Terminated NCT00984113 - Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment Phase 1
Completed NCT00842868 - The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases N/A
Completed NCT00750620 - A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment Phase 1
Completed NCT00499187 - Fanconi Syndrome Due to ARVs in HIV-Infected Persons Phase 4
Completed NCT01331941 - A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function Phase 1
Completed NCT05489614 - A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment Phase 1
Completed NCT03259087 - Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005) Phase 1
Completed NCT05086107 - Pharmacokinetics and Safety of BV100 Administered as Single Intravenous Infusion to Subjects With Renal Impairment Phase 1
Recruiting NCT05349851 - Bowel Cleansing With Renal Impairment
Completed NCT03660241 - A Renal Impairment Study for PF-04965842 Phase 1
Recruiting NCT06037031 - A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function Phase 1
Completed NCT03289208 - Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment Phase 1
Completed NCT02942810 - To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment Phase 1