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

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ClinicalTrials.gov Identifier: NCT02584569
Recruitment Status : Completed
First Posted : October 22, 2015
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: TAK-915 Phase 1

Detailed Description:

The drug being tested in this study is called TAK-915. TAK-915 is being tested to examine the degree and duration of brain phosphodiesterase 2A (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. This study will look at PDE2A brain enzyme occupancy in the putamen as a function of TAK-915 plasma concentration, as assessed using the positron emission tomography (PET) ligand [18F]MNI-794 after single dosing of TAK-915.

The study will enroll approximately 16 patients in total and within that total, allow up to 5 dose levels and up to 6 subjects per dose level. All participants will receive a single dose of TAK-915 on Day 1. The initial TAK-915 dose level to be studied is 100 mg. Subsequent dose levels may be lower or higher and will be determined through 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.

This single center trial will be conducted in the United States. The overall time to participate in this study is up to 55 days. Participants will make multiple visits to the clinic, and will be contacted by telephone 22 days after last dose of study drug for a follow-up assessment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Positron Emission Tomography Study With [18F]MNI-794 to Determine Phosphodiesterase 2A Brain Enzyme Occupancy of TAK-915 After Single-Dose Oral Administration in Healthy Subjects
Study Start Date : November 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: TAK-915
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
TAK-915 oral suspension




Primary Outcome Measures :
  1. Phosphodiesterase 2A (PDE2A) Brain Enzyme Occupancy in the Putamen as a Function of TAK-915 Plasma Concentration for each subject [ Time Frame: 2 PET scans occurring on Day 1 or 1 PET scan on Day 1 and 1 on Day 2. ]
    Assessed for each subject using the PET ligand [18F]MNI-794 after single dosing of TAK-915, obtained from non-displaceable binding potential (BPnd).


Secondary Outcome Measures :
  1. Plasma PK concentrations for each subject post tracer injection for each PET scan period following TAK-915 dosing [ Time Frame: t=0, t=45 min and t=90 min (after tracer injection) during each PET scan period. ]
  2. Dose and exposure of TAK-915 that correspond to PDE2A occupancy in the putamen of at least 45%. [ Time Frame: At multiple time points (up to 90 minutes after tracer injection) during each PET scan period. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Contraindication to magnetic resonance imaging (MRI) based on the standard MRI screening questionnaire.
  3. Have had exposure to any radiation >15 millisievert (mSv)/year (eg, occupational or radiation therapy) within the previous year prior to Baseline imaging.
  4. 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.
  5. 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.
  6. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584569


Locations
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United States, Connecticut
New Haven, Connecticut, United States
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Clinical Science Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02584569     History of Changes
Other Study ID Numbers: TAK-915-1002
U1111-1168-0766 ( Registry Identifier: WHO )
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Keywords provided by Takeda:
Drug therapy