Measurement of HTL0016878 in Cerebrospinal Fluid

NCT04849286 | Completed Phase 1

• 2 other identifiers: HTL0016878-1032018-002784-26
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, open-label, randomised, single oral dose study to determine the concentration of HTL0016878 in CSF and plasma in healthy male subjects following dosing with HTL0016878 10 mg or 20 mg oral solution

Conditions

Healthy Subjects

Keywords

Cerebrospinal Fluid

Outcome Measures

Primary Outcomes (4)

• Concentration of HTL0016878 in CSF

  Pharmacokinetics

  2 hours

• Concentration of HTL0016878 in CSF

  Pharmacokinetics

  6 hours

• Concentration of HTL0016878 in plasma Cmax

  Pharmacokinetics

  0-24 hours

• Concentration of HTL0016878 in plasma AUC

  Pharmacokinetics

  0-24 hours

Secondary Outcomes (1)

• Treatment Emergent Adverse events

  Baseline up to 10 days post-dose

Study Arms (4)

Group 1

EXPERIMENTAL

10 mg dose, CSF sample 2 hours post-dose

Drug: HTL0016878

Group 2

EXPERIMENTAL

10 mg dose, CSF sample 6 hours post-dose

Drug: HTL0016878

Group 3

EXPERIMENTAL

20 mg dose, CSF sample 2 hours post-dose

Drug: HTL0016878

Group 4

EXPERIMENTAL

20 mg dose, CSF sample 6 hours post-dose

Drug: HTL0016878

Interventions

HTL0016878 DRUG

Oral solution

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

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

You may qualify if:

• Subject has a body mass index (BMI) of 18 to 32 kg/m2, inclusive. Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, C-SSRS responses, and clinical laboratory evaluations.
• Willingness to comply with requirements or the trial, including contraception requirements.
• Able to give fully informed consent.

You may not qualify if:

• Positive tests for hepatitis B \& C, HIV. Clinically relevant history of abnormal physical or mental health. Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry or coagulation panel and urinalysis), 12-lead ECG and vital signs, or physical findings.
• History of severe adverse reactions or allergies, or history of an anaphylactic reaction to prescription or non-prescription medication or food.
• Drug or alcohol abuse. Smoking. Use of medication that inhibits CYP2D6. Participation in other clinical trials of unlicensed medicines in the previous 3 months. Loss of more than 400 mL blood in the previous 3 months. Vital signs, QTcF interval or laboratory values outside the acceptable range. Predicted poor and intermediate CYP2D6 metabolisers. Clinically relevant abnormal findings at the screening assessment. History of epilepsy or seizures. Clinically relevant abnormal medical history or concurrent medical condition disease associated with cognitive impairment and/or psychosis. History of suicidal thoughts or ideation, or any history of insomnia. Use of tobacco and/or nicotine containing products within 90 days of dosing. Habitual and heavy consumption of caffeinated beverages. Consumption of cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from these fruits) within 3 days before admission. Objection by General Practitioner

Sponsors & Collaborators

• Nxera Pharma UK Limited: lead

Study Sites (1)

MAC Clinical Research

Manchester, M13 9NQ, United Kingdom

Location

Study Design

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

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 19, 2021
• Study Start: September 26, 2018
• Primary Completion: December 7, 2018
• Study Completion: December 7, 2018
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)