This is a single-centre, open-label study in healthy male and non-pregnant, non-lactating females. The study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of Part 1 data. Part 1 is a single dose, two period crossover to assess food affect of oral BTD-001. Optional Part 2 is a non-randomised, single arm study multi dose design to evaluate PK profile of BTD-001
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
BTD-001 in fed vs fasted state
Quotient Clinical
Ruddington, Nottingham, United Kingdom
Part 1 & Part 2 - Cmax of BTD-001 and major metabolites
Maximum Observed Plasma Concentration
Time frame: [Maximum 30 days]
Part 1 & Part 2 - Tmax of BTD-001 and major metabolites
Time to Maximum Observed Plasma Concentration
Time frame: [Maximum 30 days]
Part 1 & Part 2 - AUC(0-last): of BTD-001 and major metabolites
Area Under the Curve for Observed Plasma Concentration
Time frame: [Maximum 30 days]
Part 1 & Part 2 - T1/2 of BTD-001 and major metabolites
elimination half-life
Time frame: [Maximum 30 days]
Physical Examination
Safety and tolerability of BTD-001 by assessing physical examination
Time frame: [Maximum 30 days]
Vital Signs
Safety and tolerability of BTD-001 by assessing vital signs
Time frame: [Maximum 30 days]
ECG
Safety and tolerability of BTD-001 by assessing ECG
Time frame: [Maximum 30 days]
Adverse Events
Safety and tolerability of BTD-001 by assessing AEs
Time frame: [Maximum 30 days]
Safety Lab Test
Safety and tolerability of BTD-001 by assessing safety lab tests
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: [Maximum 30 days]
Likert Scales
To assess BTD-001 withdrawal in healthy volunteers
Time frame: [Maximum 30 days]