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Trial record 9 of 1494 for:    "Kidney Failure, Chronic"

Pharmacokinetics and Safety of Alisporivir in Subjects With End Stage Renal Disease on Hemodialysis Compared to Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01975337
Recruitment Status : Completed
First Posted : November 4, 2013
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Brief Summary:
The primary objective of the study was to compare the single dose pharmacokinetics of alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of matched healthy subjects. The secondary objective was to evaluate the safety and tolerability of a single dose of alisporivir when administered to subjects with ESRD.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: Alisporivir Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: An Open-label Study to Evaluate the Pharmacokinetics and Safety of a Single Oral Dose of Alisporivir (DEB025) in Subjects With End Stage Renal Disease on Hemodialysis Compared to Matched Healthy Subjects
Study Start Date : August 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: End stage renal disease participants
End stage renal disease (ESRD) participants received a single 400 mg (2 x 200 mg capsules) oral dose of alisporivir with food at any time during the 2 hours after completion of hemodialysis on Day 1.
Drug: Alisporivir
Alisporivir supplied as 200 mg oral capsules in blister packs (7 units per blister pack)
Other Name: DEB025

Active Comparator: Matched healthy participants
Healthy participants (matched to those with end stage renal disease by sex, age, weight, and smoking status), received a single 400 mg (2 x 200 mg capsules) oral dose of alisporivir with food on Day 1.
Drug: Alisporivir
Alisporivir supplied as 200 mg oral capsules in blister packs (7 units per blister pack)
Other Name: DEB025




Primary Outcome Measures :
  1. Observed maximum plasma concentration of alisporivir following drug administration [mass / volume] (Cmax) [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose ]
  2. Area under the plasma concentration-time curve for alisporivir from time zero to time 'infinity' [mass x time / volume] (AUCinf) [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose ]
  3. Area under the plasma concentration-time curve for alisporivir from time zero to the time of the last quantifiable concentration [mass x time / volume] (AUClast) [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose ]

Secondary Outcome Measures :
  1. Time to reach peak or maximum concentration of alisporivir following drug administration [time] (Tmax) [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose ]
  2. The terminal elimination half-life [time] (T1/2) for alisporivir [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose ]
  3. Apparent systemic (or total body) clearance from plasma following extravascular administration of alisporivir [volume / time] (CL/F) [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose ]
  4. The apparent volume of distribution during the terminal elimination phase following extravascular administration of alisporivir [volume] (Vz/F) [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provides written informed consent before any assessment is performed
  • Matched healthy participants are in good health as determined by past medical history, physical examination, vital signs, laboratory tests, and other assessments
  • ESRD participants are on a protocol-defined stable hemodialysis regimen and have no evidence of hepatic decompensation, with vital signs and other tests within protocol-specified limits
  • Weighs at least 50 kg
  • Is able to communicate well with the investigator, to understand and comply with the requirements of the study.

Exclusion Criteria:

  • Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
  • Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

    1. the safety or well-being of the participant or study staff;
    2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
    3. the analysis of results

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): NCT01975337


Locations
United States, Florida
Novartis Investigative Site
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Debiopharm International SA
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT01975337     History of Changes
Other Study ID Numbers: CDEB025A2112
First Posted: November 4, 2013    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic