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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Oral solution
MAC Clinical Research
Manchester, United Kingdom
Concentration of HTL0016878 in CSF
Pharmacokinetics
Time frame: 2 hours
Concentration of HTL0016878 in CSF
Pharmacokinetics
Time frame: 6 hours
Concentration of HTL0016878 in plasma Cmax
Pharmacokinetics
Time frame: 0-24 hours
Concentration of HTL0016878 in plasma AUC
Pharmacokinetics
Time frame: 0-24 hours
Treatment Emergent Adverse events
Safety and Tolerability
Time frame: Baseline up to 10 days post-dose
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