PK and PD Study of IDN-6556 in Subjects With Severe Renal Impairment and Matched Healthy Volunteers

NCT02039817 | Completed Phase 1 Results

• 1 other identifier: IDN-6556-05
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Renal Impairment; Renal Insufficiency; Kidney Disease; Kidney Diseases

Keywords

pharmacokinetics; pharmacodynamics; renal impairment

Outcome Measures

Primary Outcomes (2)

• AUC

  Area under the plasma concentration curve (AUC) parameters include AUC0-12, AUCinf, AUClast

  48 hours

• Cmax

  Maximum concentration (Cmax)

  48 hours

Secondary Outcomes (1)

• Levels of cCK18

  48 hours

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL

All subjects receive a single 50 mg oral dose of IDN-6556

Drug: IDN-6556

Severe Renal Impairment

EXPERIMENTAL

All subjects receive a single 50 mg oral dose of IDN-6556

Drug: IDN-6556

Interventions

IDN-6556 DRUG

Also known as: emricasan, PF-03491390

Healthy Volunteers; Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \<30 mL/min using the Cockcroft-Gault equation

You may not qualify if:

• History of renal trasplant
• Acute renal failure
• Subjects undergoing any method of dialysis or hemofiltration
• Evidence or history of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
• Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal product (e.g., inflammatory bowel disease, resections of the small or large intestine, etc.)
• History of febrile illness within 5 days prior to dosing
• Evidence of clinically significant liver disease or liver damage (e.g., hepatitis B or C, autoimmune hepatitis, primary biliary cirrhosis, non-alcoholic fatty liver disease, elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that is considered clinically significant by the Investigator, etc.)
• Known infection with human immunodeficiency virus (HIV) upon serological testing
• History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of \>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)

Sponsors & Collaborators

• Conatus Pharmaceuticals Inc.: lead

Study Sites (2)

Avail Clinical Research

DeLand, Florida, 32720, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Kidney Diseases

Interventions

3-(2-(2-tert-butylphenylaminooxalyl)aminopropionylamino)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Jean L. Chan, MD
• Organization: Conatus Pharmaceuticals

jchan@conatuspharma.com

858 376 2632

Study Officials

• Dave Hagerty, MD

  Conatus Pharmaceuticals Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 20, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 28, 2016
• Results First Posted: January 28, 2016

Record last verified: 2015-12

Locations

US (2)