Food Effect, Healthy
Conditions
Keywords
Food Effect, Pharmacokinetics
Brief summary
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
Interventions
DRUGBTD-001
BTD-001 in fed vs fasted state
Sponsors
Balance Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult males and non-pregnant, non-lactating females aged 18-55 years old * BMI between18.0-35.0 kg/m2 unless investigator deems not clinically significant * Provide written consent * Agrees to protocol specified contraception
Exclusion criteria
* Received any investigational treatment within last 3 months * Subjects who are study site employees, or immediate family members of a study site or sponsor employee * Subjects who have previously been enrolled in this study * History of any drug or alcohol abuse in the past 2 years * Regular alcohol consumption in males \>21 units per week * Current smokers and those who have smoked, including nicotine replacement or e-cigarates within the last 12 months. * Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening * Clinically significant abnormal lab results * Positive drugs of abuse test result * Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results * Evidence of renal impairment at screening * History of or current seizure disorder or history of syncope, unexplained loss of consciousness or seizure in the past 3 years * Clinically significant medical/psychiatric history findings, or physical/neurological examination findings or significant history of or current suicidal ideation or behaviour * History of or current significant pulmonary, cardiac, renal, hepatic, chronic respiratory, gastrointestinal, neurological or psychiatric disease, substance dependence, porphyria, malignancy (with exception of local cutaneous squamous or basal cell carcinomas or local cervical squamous cell cancer resolved after resection) or hypothyroidism * Subjects with QT interval corrected for heart rate according to Fridericia's formula of \>430 msec in males and \>450 msec in females * Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients * Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active * Donation or loss of greater than 400 mL of blood within the previous 3 months Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than up to 4 g per day paracetamol,hormone replacement therapy and hormonal contraception) or herbal remedies * Failure to satisfy the investigator of fitness to participate for any other reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 & Part 2 - T1/2 of BTD-001 and major metabolites | [Maximum 30 days] | elimination half-life |
| Part 1 & Part 2 - Cmax of BTD-001 and major metabolites | [Maximum 30 days] | Maximum Observed Plasma Concentration |
| Part 1 & Part 2 - Tmax of BTD-001 and major metabolites | [Maximum 30 days] | Time to Maximum Observed Plasma Concentration |
| Part 1 & Part 2 - AUC(0-last): of BTD-001 and major metabolites | [Maximum 30 days] | Area Under the Curve for Observed Plasma Concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | [Maximum 30 days] | Safety and tolerability of BTD-001 by assessing AEs |
| Likert Scales | [Maximum 30 days] | To assess BTD-001 withdrawal in healthy volunteers |
| Safety Lab Test | [Maximum 30 days] | Safety and tolerability of BTD-001 by assessing safety lab tests |
| Physical Examination | [Maximum 30 days] | Safety and tolerability of BTD-001 by assessing physical examination |
| Vital Signs | [Maximum 30 days] | Safety and tolerability of BTD-001 by assessing vital signs |
| ECG | [Maximum 30 days] | Safety and tolerability of BTD-001 by assessing ECG |
Other
| Measure | Time frame | Description |
|---|---|---|
| Karolinska Sleepiness Scale | [Maximum 30 days] | To assess sleepiness using the KSS |
Countries
United Kingdom
Outcome results
None listed