CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Amphetamine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02959892
NCT02959892Phase 1Completed
CompareCT.gov

A Phase 1, Open-Label, Positron Emission Tomography Study in Healthy Subjects to Determine the Effect of TAK-041 on Amphetamine-Induced Dopamine Release in the CNS After Single-Dose Oral Administration

Neurocrine Biosciences·interventional·Posted Nov 9, 2016·Updated Mar 19, 2021

In Brief

A Phase 1 clinical trial evaluating Amphetamine, TAK -041, and 1 other intervention for Healthy Volunteers. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of this study is to determine brain penetration of single oral doses of TAK-041 and its effects on amphetamine-induced dopamine release in the Central Nervous System (CNS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited Kingdom
CollaboratorsTakeda

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 9, 2016
Enrollment StartDec 5, 2016
Primary CompletionMay 30, 2017
Study CompletionAug 23, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.6 years ago

Interventions

Amphetaminedrug

Amphetamine tablets.

TAK -041drug

TAK-041 oral suspension.

[11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO)drug

\[11C\]PHNO injection.