A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function
This study has been terminated.
(Lack of efficacy)
Sponsor:
Anthera Pharmaceuticals
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01359579
First received: May 19, 2011
Last updated: March 19, 2012
Last verified: March 2012
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Purpose
The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Impairment |
Drug: varespladib methyl |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Phase 1, Open-label, Pharmacokinetic, Safety, and Tolerability Study of a Single Oral Dose of Varespladib Methyl in Subjects With Normal Renal Function, and Subjects With Mild, Moderate, or Severe Renal Impairment |
Further study details as provided by Anthera Pharmaceuticals:
Primary Outcome Measures:
- Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function [ Time Frame: PK samples will be collected predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48, and 72 hours postdose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety measures to include adverse events and changes in clinical laboratory results [ Time Frame: From admistration of study drug through follow-up on Day 8 ] [ Designated as safety issue: No ]
| Enrollment: | 28 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Subjects with mild renal impairment |
Drug: varespladib methyl
Single oral 500 mg dose
|
| Experimental: Subjects with moderate renal impairment |
Drug: varespladib methyl
Single oral 500 mg dose
|
| Experimental: Subjects with normal renal function |
Drug: varespladib methyl
Single oral 500 mg dose
|
| Experimental: Subjects with severe renal impairment |
Drug: varespladib methyl
Single oral 500 mg dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Males and non-pregnant, non-lactating females 18 years or older with a BMI of 18-40 kg/m2 inclusive.
- Regarding renal function, subjects will be classified as either normal or as suffering from mild,moderate or severe renal impairment. Classification of renal impairment will be estimated by the MDRD and Cockcroft-Gault formulae
Exclusion Criteria:
- Any disease, condition and/or chronic medications which might compromise the hematologic, cardiovascular, pulmonary renal, gastrointestinal, hepatic, or central nervous system; or other conditions that might interfere with the distribution, metabolism or excretion of study drug, or would place the subject at increased risk
- Evidence of significant respiratory, gastrointestinal or hepatic disease at screening
- Positive screen for hepatitis B surface antigen, or HIV
- Positive test in drugs of abuse screens or alcohol on admission to the clinic
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359579
Locations
| United States, Florida | |
| Investigator Site 101 | |
| Orlando, Florida, United States, 32809 | |
| United States, Minnesota | |
| Investigator Site 102 | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, Tennessee | |
| Investigator Site 103 | |
| Knoxville, Tennessee, United States, 37920 | |
Sponsors and Collaborators
Anthera Pharmaceuticals
More Information
No publications provided
| Responsible Party: | Anthera Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01359579 History of Changes |
| Other Study ID Numbers: | AN-CVD2213 |
| Study First Received: | May 19, 2011 |
| Last Updated: | March 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Anthera Pharmaceuticals:
|
renal impairment phase 1 healthy volunteers |
Additional relevant MeSH terms:
|
Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013