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A Study to Evaluate ID-085 in People With Mild, Moderate, and Severe Kidney Disease

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ClinicalTrials.gov Identifier: NCT03913000
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief 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

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: ID-085 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Single-center, open-label, single-dose study is conducted in male and female subjects with renal function impairment and in healthy subjects. Groups A (mild), B (moderate), C (severe) and D (healthy subjects) will be studied in a staggered way, starting with the group with mild renal function impairment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Open-label, Phase 1 Study to Investigate the Effects of Mild, Moderate, and Severe Renal Function Impairment on the Pharmacokinetics, Safety, and Tolerability of a Single Dose of ID-085
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Arm Intervention/treatment
Experimental: ID-085 single dose
Administration of the study treatment 200 mg to renally impaired subjects will be done by severity, starting with group A (mild), and followed by group B (moderate), C (severe) and D (healthy subjects).
Drug: ID-085
Hard capsules for oral administration formulated at a strength of 200 mg




Primary Outcome Measures :
  1. 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) [ Time Frame: Up to Day 3 after treatment administration ]
    Will be derived by non-compartmental analysis of the plasma concentration-time profiles

  2. The plasma AUC from zero to infinity (AUC0-inf), calculated with the apparent λz [ Time Frame: Up to Day 3 after treatment administration ]
    Will be derived by non-compartmental analysis of the plasma concentration-time profiles

  3. The maximum plasma concentration (Cmax) [ Time Frame: Up to Day 3 after treatment administration ]
    Will be derived by non-compartmental analysis of the plasma concentration-time profiles

  4. The time to reach Cmax (tmax) [ Time Frame: Up to Day 3 after treatment administration ]
    Will be derived by non-compartmental analysis of the plasma concentration-time profiles

  5. Apparent total body clearance (CL/F) [ Time Frame: Up to Day 3 after treatment administration ]
    Will be derived by non-compartmental analysis of the plasma concentration-time profiles

  6. Apparent volume of distribution (Vz/F) [ Time Frame: Up to Day 3 after treatment administration ]
    Will be derived by non-compartmental analysis of the plasma concentration-time profiles



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913000


Contacts
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Contact: CTD Clinical Trial Disclosure desk +18566613721 clinical-trials-disclosure@idorsia.com

Locations
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Germany
CRS Clinical Research Services Kiel GmbH Recruiting
Kiel, Germany, 24105
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.

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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03913000     History of Changes
Other Study ID Numbers: ID-085-103
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases