NCT04849286

Measurement of HTL0016878 in Cerebrospinal Fluid

A Phase 1, Open-label, Randomised, Single-centre, Single Oral Dose Study to Determine the Concentration of HTL0016878 in Cerebrospinal Fluid and Plasma in Healthy Male Subjects Following Dosing With HTL0016878 Oral Solution

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Nxera Pharma UK Limited · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

Up to 24 healthy subjects will be enrolled into 4 groups, with 6 subjects per group. Each subject will be randomised to receive a single oral dose of 10 mg or 20 mg HTL0016878 solution and will have a single CSF sample taken via lumbar puncture at either 2 or 6 hours post-dose. Pharmacokinetic blood sampling and safety measures will continue until 24 hours post-dose.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	HTL0016878	Oral solution

Timeline

• Start date: 2018-09-26
• Primary completion: 2018-12-07
• Completion: 2018-12-07
• First posted: 2021-04-19
• Last updated: 2021-04-19

Locations

1 site across 1 country: United Kingdom