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A Study to Evaluate Abuse Potential of Istradefylline
NCT02609477 · View on ClinicalTrials.gov ↗
Study Summary
This study is to evaluate the abuse potential of single-doses of istradefylline compared to placebo and phentermine in recreational stimulant users. Subjects will participate in an outpatient medical Screening visit, a 5-day Qualification (Drug Discrimination) Phase, a 6-period Treatment Phase, and an outpatient safety Follow-Up visit. Study will be approximately 25 weeks total. Within 28 days of the Screening visit, eligible subjects will be admitted to the CRU (Day -1) for the Qualification Phase. During the Qualification Phase, subjects will receive single oral doses of phentermine 60 mg and matching placebo in a randomized, double blind, crossover manner, with each drug administration separated by approximately 48 hours (Day 1 and Day 3), to ensure that they can discriminate and show positive subjective effects of the active controls. Following evaluation of eligibility, subjects may be discharged (those who fail Qualification criteria) or remain in the CRU (those who pass criteria and are eligible) and then proceed directly to the Treatment Phase. The washout interval between last drug administration in the Qualification Phase and first drug administration in the Treatment Phase will be at least 96 hours (4 days). Following confirmation of eligibility from the Qualification Phase, subjects will be randomized to one of 6 treatment sequences according to a 6x6 Williams square. Subjects will receive single oral doses of each of the 6 treatments in a randomized, double-blind, crossover manner, Istradefylline 40 mg, Istradefylline 80 mg, Istradefylline 160 mg, Phentermine 45 mg, Phentermine 90 mg, Placebo. Each drug administration will be separated by at least 21 days. Serial pharmacodynamic evaluations will be conducted up to 24 hours after each study drug administration to confirm exposure to istradefylline.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Istradefylline
- DRUG Phentermine 45 mg
Study Locations (1)
Utah
- Pharmaceutical Research Associates, Inc — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2016-01 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02609477
The ClinicalTrials.gov registry entry for NCT02609477 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kyowa Kirin Co., which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Drug Abuse appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02609477 reports 1 study location spanning 1 distinct geographic area — top geographies include Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02609477 about?
NCT02609477 is a clinical study titled "A Study to Evaluate Abuse Potential of Istradefylline". This study is to evaluate the abuse potential of single-doses of istradefylline compared to placebo and phentermine in recreational stimulant users. Subjects will participate in an outpatient medical Screening visit, a 5-day Qualification (Drug Discrimination) Phase, a 6-period Treatment Phase, and ...
What is the current status of trial NCT02609477?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2016-01. Estimated completion is 2016-07.
What conditions does trial NCT02609477 study?
This clinical trial studies the following conditions: Drug Abuse. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02609477?
The interventions under investigation include: Placebo (OTHER), Istradefylline (DRUG), Phentermine 45 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02609477?
This trial is sponsored by Kyowa Kirin Co., which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02609477 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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