Trial record 2 of 21 for:    istradefylline

The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT02174250
First received: June 24, 2014
Last updated: May 19, 2015
Last verified: May 2015

June 24, 2014
May 19, 2015
June 2014
May 2015   (final data collection date for primary outcome measure)
Area under the concentration-time curve from time zero to infinity (AUC0 ∞) and Observed maximum plasma concentration (Cmax) of istradefylline [ Time Frame: Intermittently for a total of 62 days ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve from time zero to infinity (AUC0 ∞) [ Time Frame: Intermittently for a total of 62 days ] [ Designated as safety issue: No ]
  • Observed maximum plasma concentration (Cmax) of istradefylline [ Time Frame: Intermittently for up to 62 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT02174250 on ClinicalTrials.gov Archive Site
Number of serious adverse events, and non-serious adverse events [ Time Frame: Continuously for up to 74 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.
Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline in Healthy Subjects

The purpose of this study is to test whether Rifampin affects blood levels of istradefylline in humans. Rifampin could possibly decrease istradefylline levels.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Parkinson's Disease
  • Drug: Istradefylline 40 mg
    On Day 1, istradefylline 1 × 40-mg tablet administered alone
    Other Name: KW-6002
  • Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 only
    On Days 1 - 20, rifampin 300mg BID; On Day 8, istradefylline 40 mg administered first with rifampin about 2 hours after istradefylline administration
    Other Name: rifadin
  • Experimental: Istradefylline 40mg
    Period 1: Day 1, istradefylline 40mg then crossover to Period 2
    Intervention: Drug: Istradefylline 40 mg
  • Experimental: Rifampin 300mg BID + istradefylline 40mg
    Period 2: Days 1-20 rifampin 300mg BID + istradefylline 40mg Day 8 only
    Interventions:
    • Drug: Istradefylline 40 mg
    • Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy non-smoking male and post-menopausal female subjects
  • Body Mass Index: 18.0-35.0 kg/m2, inclusive
  • Subjects must not be taking drugs that are moderate to potent inhibitors of CYP3A4 or CYP1A2.
  • Subjects without clinically significant medical history in the judgment of the investigator
  • Subjects without clinically significant laboratory or ECG abnormalities

Exclusion Criteria:

  • Females that are pregnant or lactating
  • Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study;
  • Known history of treatment for drug or alcohol addiction within the previous 12 months;
  • Subjects with an average alcohol intake of more than 2 units per day or 14 units per week up to 48 hours prior to the istradefylline dose on Day 1. One unit of alcohol is ½ pint of beer (285 mL) or 1 glass of spirits (25 mL) or 1 glass of wine (125 mL);
  • Donated or lost > 500 mL of blood within 3 months prior to istradefylline dose on Day 1 of Period 1;
  • Positive test results for human immunodeficiency virus (HIV) or Hepatitis B surface antigen, or Hepatitis C;
  • Positive test results for drugs of abuse at screening;
  • Unable, or unwilling to tolerate multiple venipunctures;
  • Difficulty fasting or eating the standard meals that will be provided;
  • Use of tobacco or nicotine-containing products within 90 days of the study start to the Follow-up visit
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02174250
6002-015
No
Kyowa Hakko Kirin Pharma, Inc.
Kyowa Hakko Kirin Pharma, Inc.
Not Provided
Study Chair: Marc Cantillon, M.D. Kyowa Hakko Kirin Pharma, Inc.
Study Director: Amy Zhang, PhD Kyowa Hakko Kirin Pharma, Inc.
Kyowa Hakko Kirin Pharma, Inc.
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP