Approval Probability
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Adjusted LOA
ML Risk
Amphetamine · 1 trial · 1 indication
The AMPH-induced change in binding potential relative to the non-displaceable component in the basal ganglia (putamen \[Pu\], ventral striatum \[VSt\]) which was the region of interest (ROI) was calculated as the percentage of reduction in specific binding from Baseline to postdose following AMPH.
| Arm | Type | Description |
|---|---|---|
| TAK-041 20 mg | EXPERIMENTAL | \[11C\] PHNO 180 megabecquerel (MBq), injection, intravenously, prior to positron emission tomography (PET) scan on Day 1, followed by amphetamine (AMPH) 0.5 milligram per kilogram (mg/kg), tablet, orally, once and \[11C\] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 2 of Confinement Period 1, followed by a 5 to 45 days of interval period, further followed by TAK-041 20 mg, suspension, orally, once, followed by AMPH 0.5 mg, tablet, orally, once and \[11C\] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 1 of Confinement Period 2. |
| TAK-041 40 mg | EXPERIMENTAL | \[11C\] PHNO 180 MBq, injection, intravenously, prior to PET scan on Day 1, followed by AMPH 0.5 mg/kg, tablet, orally, once and \[11C\] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 2 of Confinement Period 1, followed by a 5 to 45 days of interval period, further followed by TAK-041 40 mg, suspension, orally, once, followed by AMPH 0.5 mg, tablet, orally, once and \[11C\] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 1 of Confinement Period 2. |
| Name | Type | Description |
|---|---|---|
| Amphetamine | DRUG | Amphetamine tablets. |
| TAK -041 | DRUG | TAK-041 oral suspension. |
| [11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO) | DRUG | \[11C\]PHNO injection. |
Inclusion Criteria: 1. Is in good health as determined by physical examination, electrocardiogram (ECG), and laboratory evaluations. 2. Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m\^2), inclusive, at Screening. Exclusion Criteri...
Amphetamine is an investigational small molecule being studied in healthy volunteers. It is being used in a clinical trial to determine its effect on dopamine release in the central nervous system. The drug is not approved for any indication and is in Phase 1 clinical development.
Amphetamine is being developed by Neurocrine Biosciences, Inc. (NASDAQ: NBIX). The company is conducting clinical research on the drug, which is currently in Phase 1 development for use in healthy volunteers.
Amphetamine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its effects on dopamine release in the central nervous system.
Amphetamine is associated with one completed Phase 1 clinical trial, NCT02959892. This single-dose positron emission tomography (PET) study was conducted in the United Kingdom to determine the effect of TAK-041 on amphetamine-induced dopamine release in the central nervous system. The trial enrolled 12 healthy male volunteers.
Amphetamine is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, and its safety and efficacy have not been established for any medical condition.