A Study to Evaluate Abuse Potential of Istradefylline

Drug Abuse Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo- and Active-Controlled Crossover Study to Evaluate the Abuse Potential of Istradefylline in Recreational Drug Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609477
• Other study ID #: 6002-017
• Status: Completed
• Phase: Phase 1
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subjects who will provide written informed consent

• Healthy volunteer, male and female between 18 and 55 years of age, inclusive

• Subjects with a body mass index (BMI) within 18.0 to 33.0 kg/m2, inclusive

• Subjects who are recreational drug user

Exclusion Criteria:

• Subjects who have an alcohol or substance dependence within the 12 months

• Subjects who have ever been in treatment for substance use disorder

• Subjects who consume on average more than 5 servings of caffeinated beverages per day

• Subjects with a history of or presence of any clinically significant cardiovascular disease

• Subject with hyperthyroidism or glaucoma.

Related Conditions & MeSH terms

• Drug Abuse
• Substance-Related Disorders

Intervention

Drug:
• Istradefylline
Istradefylline 40, 80, 160 mg
• Phentermine 45 mg
Phentermine 45 or 90 mg

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Pharmaceutical Research Associates, Inc	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.	Kyowa Hakko Kirin Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug Liking VAS	To evaluate the abuse potential of istradefylline compared to phentermine and placebo.	24 hours
Secondary	C-SSRS (Columbia Suicide Severity Rating Scale)	To evaluate the safety and tolerability of istradefylline.	24 hours
Secondary	Alerness/Drowsiness, Agitation/Relaxation VAS	To evaluate the safety and tolerability of istradefylline.	24 hours
Secondary	Caffine Withdrawal/Symptom Questionnaire	To evaluate the safety and tolerability of istradefylline.	24 hours
Secondary	Overall Drug Liking, Take Drug Again VAS	To evaluate the safety and tolerability of istradefylline.	24 hours
Secondary	Drug Similarity VAS	To evaluate the safety and tolerability of istradefylline.	24 hours