Phase 1
N=16
PK and PD Study of IDN-6556 in Subjects With Severe Renal Impairment and Matched Healthy Volunteers
Renal Impairment · Renal Insufficiency · Kidney Disease · Kidney Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02039817 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: AUC — 102.0; 168.9; 107.4; 188.5 h*ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- IDN-6556 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Conatus Pharmaceuticals Inc.
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC |
102.0; 168.9; 107.4; 188.5; 105.9; 186.5 | — |
| PRIMARY Cmax |
28.5; 42.7 | — |
| SECONDARY Levels of cCK18 |
240.0; 223.5; 201.5; 202.5; 208.0; 191.5 | — |
Summary
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with severe renal impairment and matched healthy volunteers with normal renal function.
Eligibility Criteria
Inclusion Criteria
All Subjects:
- Male or female subjects 18 - 75 years of age, able to provide written informed consent, understand and comply with all scheduled visits, and other requirements of the study
- Body mass index (BMI) 18.0 - 40.0 kg/m2 and body weight >50 kg
- Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to one month after the last dose of study drug
Matched Healthy Volunteers:
- Medically healthy as determined by the Investigator
- Screening creatinine clearance ≥90 mL/min using the Cockcroft-Gault equation
- Supine blood pressure ≤145/90 mmHg
- No significant uncontrolled systemic or major illness that, in the opinion of the Investigator, would preclude the subject from participating in and completing the study
- Demographically comparable to subjects with severe renal impairment as follows:
- Mean body weight within ±10 kg
- Mean age within ±5 years
- Similar gender ratio
Severe Renal Impaired Subjects:
- Screening creatinine clearance (CLCR) 480 milliseconds (msec) for subjects with severe renal impairment or >450 msec for matched healthy volunteers
- Subjects with active or history of malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
Data sourced from ClinicalTrials.gov (NCT02039817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.