D1 Receptor Occupancy (RO) Following a Single Dose of PF-06412562

NCT03686501 | Completed Early Phase 1 FDA Drug

• 1 other identifier: [18F] MNI-968
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the D1 receptor occupancy (D1 RO) in striatum after a single oral administration of PF-06412562.

Conditions

Healthy Male Volunteers

Keywords

HV

Outcome Measures

Primary Outcomes (1)

• Evaluate D1 Receptor Occupancy (RO) Following a Single Dose of PF-06412562, Using Positron Emission Tomography (PET) with Ligand [18F]MNI-968

  1 year

Study Arms (1)

PF-06412562

EXPERIMENTAL

To assess the D1 receptor occupancy (D1 RO) in striatum after a single oral administration of PF-06412562.

Drug: PF-06412562

Interventions

PF-06412562 DRUG

Healthy Volunteers recruited for the study will undergo a single dose of PF-06412562 and will undergo two \[18F\]MNI-968 injections

Also known as: [18F]MNI-968 (PF-06730110)

PF-06412562

Eligibility Criteria

• Age: 20 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before subjects are included in the study.
• Signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study prior to the initiation of any study assessments.
• Healthy male subjects between the ages of 20 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests, in the opinion of the investigator).
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
• Male subjects must not donate sperm for the study duration.
• Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory test and other study procedures.

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• Evidence or history of clinically significant hepatic, renal, cardiovascular, endocrine, hematologic, gastrointestinal, pulmonary, neurologic, oncologic, psychiatric, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). This also includes subjects with previous history of epilepsy or seizures, clinically significant abnormal electroencephalogram (EEG), febrile convulsion, head injury with significant sequelae, psychiatric illness, attempted suicide or suicidal ideation.
• Any condition possibly affecting drug absorption (eg, gastrectomy)
• A positive urine drug screen (confirmed by repeat) Protocol 4006 Version 1.0; 20 April 2018 Confidential and Proprietary
• History of regular alcohol consumption exceeding 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the dose of study medication.
• Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of rest. If blood pressure (BP) is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility.
• lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
• Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
• Use of prescription drugs within 7 days or 5 half-lives (whichever is longer) prior to the dose of study medication. As an exception, acetaminophen/paracetamol may be used "as needed" (prn) and only at doses of ≤1 g/day.
• Blood donation or loss (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
• History of sensitivity to heparin or heparin-induced thrombocytopenia.
• Unwilling or unable to comply with the Life Style Guidelines described in this protocol.
• Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• A lifetime history of seizure disorder of any etiology, inclusive of childhood seizures.

Sponsors & Collaborators

• Invicro: lead

Study Sites (1)

Invicro

New Haven, Connecticut, 06510, United States

Location

Related Links

• Related Info

Study Design

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

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 27, 2018
• Study Start: September 10, 2018
• Primary Completion: March 28, 2019
• Study Completion: March 28, 2019
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

US (1)