A Study to Evaluate Abuse Potential of Istradefylline

NCT02609477 | Completed Phase 1

• 1 other identifier: 6002-017
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Drug Abuse

Keywords

Recreational stimulant users; Recreational Drug Users

Outcome Measures

Primary Outcomes (1)

• Drug Liking VAS

  To evaluate the abuse potential of istradefylline compared to phentermine and placebo.

  24 hours

Secondary Outcomes (5)

• C-SSRS (Columbia Suicide Severity Rating Scale)

  24 hours

• Alerness/Drowsiness, Agitation/Relaxation VAS

  24 hours

• Caffine Withdrawal/Symptom Questionnaire

  24 hours

• Overall Drug Liking, Take Drug Again VAS

  24 hours

• Drug Similarity VAS

  24 hours

Study Arms (6)

Istradefylline 40 mg

EXPERIMENTAL

40 mg istradefylline (1 × 40 mg tablet + 3 × placebo tablets + 3 × placebo capsules)

Drug: Istradefylline; Other: Placebo

Istradefylline 80 mg

EXPERIMENTAL

80 mg istradefylline (2 × 40 mg tablets + 2 × placebo tablets + 3 × placebo capsules)

Drug: Istradefylline; Other: Placebo

Istradefylline 160 mg

EXPERIMENTAL

160 mg istradefylline (4 × 40 mg tablets + 3 × placebo capsules)

Drug: Istradefylline; Other: Placebo

Phentermine 45 mg

ACTIVE COMPARATOR

45 mg phentermine (4 x placebo tablets + 3 × 15 mg phentermine hydrochloride capsules)

Drug: Phentermine 45 mg; Other: Placebo

Phentermine 90 mg

ACTIVE COMPARATOR

90 mg phentermine (4 × placebo tablets + 3 × 30 mg phentermine hydrochloride capsules)

Drug: Phentermine 45 mg; Other: Placebo

Placebo

PLACEBO COMPARATOR

Placebo (4 × placebo tablets + 3 × placebo capsules)

Other: Placebo

Interventions

Istradefylline DRUG

Istradefylline 40, 80, 160 mg

Also known as: 6002

Istradefylline 160 mg; Istradefylline 40 mg; Istradefylline 80 mg

Phentermine 45 mg DRUG

Phentermine 45 or 90 mg

Phentermine 45 mg; Phentermine 90 mg

Placebo OTHER

Placebo

Istradefylline 160 mg; Istradefylline 40 mg; Istradefylline 80 mg; Phentermine 45 mg; Phentermine 90 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead
• Kyowa Hakko Kirin Pharma, Inc.: collaborator

Study Sites (1)

Pharmaceutical Research Associates, Inc

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

istradefylline; Phentermine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Kyowa Hakko Kirin Pharma, Inc.

  Kyowa Hakko Kirin Pharma, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 20, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 25, 2024

Record last verified: 2016-08

Locations

US (1)