Phase 1 TAK-915 Single-Dose Positron Emission Tomography (PET) Occupancy Study

NCT02584569 | Completed Phase 1

• 2 other identifiers: TAK-915-1002U1111-1168-0766
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 1 study will be conducted to examine the degree and duration of brain PDE2A enzyme occupancy /target engagement as a function of TAK-915 plasma concentration in order to guide dosing and schedule for future clinical studies in schizophrenia with TAK-915.

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Phosphodiesterase 2A (PDE2A) Brain Enzyme Occupancy in the Putamen as a Function of TAK-915 Plasma Concentration for each subject

  Assessed for each subject using the PET ligand \[18F\]MNI-794 after single dosing of TAK-915, obtained from non-displaceable binding potential (BPnd).

  2 PET scans occurring on Day 1 or 1 PET scan on Day 1 and 1 on Day 2.

Secondary Outcomes (2)

• Plasma PK concentrations for each subject post tracer injection for each PET scan period following TAK-915 dosing

  t=0, t=45 min and t=90 min (after tracer injection) during each PET scan period.

• Dose and exposure of TAK-915 that correspond to PDE2A occupancy in the putamen of at least 45%.

  At multiple time points (up to 90 minutes after tracer injection) during each PET scan period.

Study Arms (1)

TAK-915

EXPERIMENTAL

TAK-915 100 mg suspension, orally, once on Day 1. Additional TAK-915 dose levels may be incorporated based on dose level review meetings (DLRMs) following approximately every 2 participants and based on prior occupancy, duration of occupancy, safety, tolerability, and available pharmacokinetic (PK) data.

Drug: TAK-915

Interventions

TAK-915 DRUG

TAK-915 oral suspension

TAK-915

Eligibility Criteria

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

You may qualify if:

• Is a healthy male, or female of non-childbearing potential, aged between 18 and 55 years, inclusive.
• Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m\^2.

You may not qualify if:

• Has a known history or evidence of a clinically significant disorder (including neurologic and psychiatric) or disease that in the opinion of the study investigator would pose a risk to the participant's safety or interfere with the study evaluation, procedures, or completion.
• Contraindication to magnetic resonance imaging (MRI) based on the standard MRI screening questionnaire.
• Have had exposure to any radiation \>15 millisievert (mSv)/year (eg, occupational or radiation therapy) within the previous year prior to Baseline imaging.
• Has a known hypersensitivity to any component of the formulation of TAK-915 or related compounds, or to \[18F\]MNI-794 or to any of its components.
• Clinically significant abnormal findings on brain MRI scan or findings on brain MRI that may interfere with the interpretation of the positron emission tomography (PET) imaging.
• Use of any herbal or prescription medications within 30 days prior to Baseline Imaging Check-in; use of any over-the-counter medications or vitamin supplements within 7 days prior to Baseline Imaging Check-in.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

New Haven, Connecticut, United States

Location

MeSH Terms

Interventions

TAK-915

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 22, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 21, 2016

Record last verified: 2016-07

Locations

US (1)