Study to Investigate the Receptor Occupancy of HTL0014242 Using [18F] FPEB in Healthy Male Subjects

NCT04462263 | Completed Phase 1

• 3 other identifiers: HTL0014242-1032020-000602-28247490
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

A Study in Healthy Volunteers to Investigate How a New Drug for the Treatment of Parkinson's Disease, Dystonia and Amyotrophic Lateral Sclerosis Binds to Receptor Sites in the Brain.

Conditions

Healthy

Keywords

Single dose; Open-label; Oral

Outcome Measures

Primary Outcomes (2)

• Receptor Occupancy Endpoint

  The regional brain Receptor Occupancy profile of HTL0014242, measured by Positron Emission Tomography (PET) imaging with\[18F\]FPEB

  Day 1 post-dose timepoint

• Receptor Occupancy Endpoint

  The regional brain Receptor Occupancy profile of HTL0014242, measured by Positron Emission Tomography (PET) imaging with\[18F\]FPEB

  Day 2 post-dose timepoint

Secondary Outcomes (6)

• Cmax: Maximum plasma concentration

  Baseline up to 14(+3) days post dose

• Area under the plasma-concentration curve

  Baseline up to 14(+3) days post dose

• Time to Maximum plasma concentration (Tmax) of HTL0014242

  Baseline up to 14(+3) days post dose

• Half-life (t1/2) of HTL0014242

  Baseline up to 14(+3) days post dose

• Apparent total plasma clearance (CL/F)

  Baseline up to 14(+3) days post dose

Study Arms (1)

Single Dose HTL0014242

EXPERIMENTAL

The study consists of up to 5 dosing groups, with 2 to 3 subjects per dosing group. Each subject will receive a single oral dose of HTL0014242 in the form of solid suspension capsules (1, 5, 10, and 30mg) as required. HTL0014242 will be administered in up to 5 single dose groups, with 120mg administered in the first dosing group.

Drug: HTL0014242

Interventions

HTL0014242 DRUG

Solid suspension capsule

Single Dose HTL0014242

Eligibility Criteria

• Age: 23 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male, aged between 23 and 55 years inclusive, with body mass index between 18.5 and 32 kg/m2.
• Healthy on the basis of a clinical history, physical examination, electrocardiogram (ECG), vital signs and laboratory tests of blood and urine.
• Able to give fully informed consent and has suitable veins for cannulation and arterial access in both wrists
• Resting BP and heart rate within normal ranges after 5 mins rest.

You may not qualify if:

• Past, current or family history of mental, behavioural or neurodevelopmental disorder.
• Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, pyschiatric disorders, metabolic, allergic, dermatological, haematological, pulmonary or respiratory disorder.
• History of significant hypersensitivity, intolerance or allergy to any drug compound, food or other substance, unless approved by Investigator.
• Active neoplastic disease or history of any neoplastic disease within 5 years of screening.
• Active infection (e.g sepsis, pneumonia, abscess) or serious infection (e.g resulting in hospitalisation or requiring parenteral antibiotic treatment) within 90 days prior to dosing.
• History of stomach or intestinal surgery or resection.
• Any of following at screening or pre-dose: QT internal heart rate correction; QRS duration \>120ms; PR interval \> 220ms; QTc measurements/data difficult or uninterpreable; history of additional risk factors for torsades de pointe.
• drug or alcohol abuse in last 2 years.
• Alcohol consumption is \> 14 units per week
• Positive Urine alcohol or drug tests
• Positive HIV, Hep B, Hep C test
• Aspartate aminotransferase, Alanine aminotransferase, Gamma glutamyl transferase, Alkaline phosphatase or total bilirubin above normal upper limits
• Participation in other clinical trials of unlicensed medicines in the previous 3 months, or 7 half-lives of the medicine (whichever is longer)
• Previously dosed with HTL0014242.
• Intention to use or using medications that interfere with drug absorption, metabolism or elimination processes incl St John's Wort, 30 days prior to dosing.

Sponsors & Collaborators

• Nxera Pharma UK Limited: lead

Study Sites (1)

Parexel Early Phase Clinical Unit

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

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: June 29, 2020
• First Posted: July 8, 2020
• Study Start: June 29, 2020
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)