NCT03200080

Brief Summary

This will be a single-dose, randomized, double-blind, active- and placebo-controlled, double dummy, 6-way crossover study to determine the abuse potential of tozadenant relative to d-amphetamine and placebo, when administered orally in healthy non-dependent, recreational polydrug users with stimulant experience, under fed conditions. Each subject will participate in a medical Screening visit, a 4-day (3-night) qualification (drug discrimination) visit, six 3-day (2-night) treatment periods, and a follow-up visit.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 18, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2017

Completed
Last Updated

August 13, 2018

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

March 14, 2017

Last Update Submit

August 9, 2018

Conditions

Abuse Potential

Outcome Measures

Primary Outcomes (1)

  • Drug Liking

    Drug Liking Visual Analog Scale (VAS) ("at this moment"), assessed on a bipolar, 0- to 100-point visual analog scale.

    24 hours

Secondary Outcomes (14)

  • Balance of effects

    24 hours

  • Global effects

    24 hours

  • Positive drug effects

    24 hours

  • Positive drug effects

    24 hours

  • Negative drug effects

    24 hours

  • +9 more secondary outcomes

Study Arms (6)

Treatment A

PLACEBO COMPARATOR

Placebo oral tablet and Placebo oral capsule

Drug: Placebo oral tabletDrug: Placebo oral capsule

Treatment B

EXPERIMENTAL

Tozadenant 120 mg

Drug: TozadenantDrug: Placebo oral capsule

Treatment C

EXPERIMENTAL

Tozadenant 240 mg

Drug: TozadenantDrug: Placebo oral capsule

Treatment D

EXPERIMENTAL

Tozadenant 480 mg

Drug: TozadenantDrug: Placebo oral capsule

Treatment E

ACTIVE COMPARATOR

d-amphetamine 20 mg

Drug: Placebo oral tabletDrug: d-amphetamine

Treatment F

ACTIVE COMPARATOR

d-amphetamine 40 mg

Drug: Placebo oral tabletDrug: d-amphetamine

Interventions

TozadenantDRUG

2, 4, 6 or 8 Tozadenant 60 mg tablets

Also known as: SYN115
Treatment BTreatment CTreatment D
Placebo oral tabletDRUG

2, 4, 6 or 8 Tozadenant matching placebo tablets

Treatment ATreatment ETreatment F
d-amphetamineDRUG

2 or 4 capsules, each containing 2 over-encapsulated d-amphetamine 5 mg tablets

Treatment ETreatment F
Placebo oral capsuleDRUG

2 or 4 capsules, each containing d-amphetamine matching over-encapsulated PLACEBO 200 mg lactose tablet

Treatment ATreatment BTreatment CTreatment D

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female subjects 18 to 55 years of age, inclusive.
  • Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 and a minimum weight of at least 50.0 kg
  • Current recreational polydrug users who self-report to:
  • Have used stimulants (e.g., amphetamines, cocaine, methylphenidate) for non-therapeutic purposes (i.e., for psychoactive effects) at least 10 times in the past year and at least 1 time in the 8 weeks before Screening.
  • Have at least 10 lifetime uses of drugs (e.g., opioids, sedatives) from at least 1 other class other than alcohol.
  • Agree to use an approved method of contraception
  • Be willing and able to abide by all study requirements and restrictions
  • Additional criteria may apply

You may not qualify if:

  • Substance or alcohol dependence within the past 2 years,
  • Clinically significant medical history or illness
  • Female subjects who have a positive pregnancy test, are currently pregnant or lactating, or who are planning to become pregnant within 30 days of last study drug administration.
  • Donation or loss of more than 500 mL whole blood within 30 days preceding the Screening visit.
  • Additional criteria may apply.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INC Research Toronto, Inc.

Toronto, Ontario, M5V 2T3, Canada

Location

MeSH Terms

Interventions

tozadenantDextroamphetamine

Intervention Hierarchy (Ancestors)

AmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Michael McDonnell, MD

    INC Research Toronto

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 14, 2017

First Posted

June 27, 2017

Study Start

September 18, 2017

Primary Completion

November 28, 2017

Study Completion

November 28, 2017

Last Updated

August 13, 2018

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)