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Renal ImpairmentPhase 1NCT03913000

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

A Phase 1 study testing ID-085 in people with Renal Impairment, run by Idorsia Pharmaceuticals Ltd. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Renal Impairment
What is being tested?
ID-085
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteGermany
Study dates
29 Apr 2019to 22 Aug 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • CRS Clinical Research Services Kiel GmbH

    Kiel, 24105

Other trials in Germany

About this study

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

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

Being tested
ID-085
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ID-085Drug

    Hard capsules for oral administration formulated at a strength of 200 mg

Study groups in NCT03913000
Study groupRoleWhat they receive
ID-085 single doseExperimentalAdministration 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).
Receives: Drug: ID-085

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Will be derived by non-compartmental analysis of the plasma concentration-time profiles

    Measured: Up to Day 3 after treatment administration

  2. The plasma AUC from zero to infinity (AUC0-inf), calculated with the apparent λz

    Will be derived by non-compartmental analysis of the plasma concentration-time profiles

    Measured: Up to Day 3 after treatment administration

  3. The maximum plasma concentration (Cmax)

    Will be derived by non-compartmental analysis of the plasma concentration-time profiles

    Measured: Up to Day 3 after treatment administration

  4. The time to reach Cmax (tmax)

    Will be derived by non-compartmental analysis of the plasma concentration-time profiles

    Measured: Up to Day 3 after treatment administration

  5. Apparent total body clearance (CL/F)

    Will be derived by non-compartmental analysis of the plasma concentration-time profiles

    Measured: Up to Day 3 after treatment administration

  6. Apparent volume of distribution (Vz/F)

    Will be derived by non-compartmental analysis of the plasma concentration-time profiles

    Measured: Up to Day 3 after treatment administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2019
  2. Study start29 Apr 2019
  3. Primary completion22 Aug 2019
  4. Study completion22 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Intervention model
Sequential
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)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03913000
Sponsor's protocol ID
ID-085-103
Status last verified
Nov 2019
First submitted
10 Apr 2019
Last updated
22 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ID-085 in people with Renal Impairment, run by Idorsia Pharmaceuticals Ltd. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03913000.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.

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