A Food Effects Study and Optional Multi Dose Study to Assess PK of BTD-001

Study Overview
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Brief Summary
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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

Official Title
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A Phase 1 Cross-over Study to Determine Food Effects on the Pharmacokinetics of Oral BTD-001 and Metabolites in Healthy Volunteers, Followed by an Optional Multiple Dose Study to Assess Pharmacokinetics of Oral BTD-001

Conditions
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Food Effect, Healthy

Intervention / Treatment
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* Drug: BTD-001


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTD-001 (fed)<br> | Drug: BTD-001<br>* BTD-001 in fed vs fasted state<br>|
| Experimental: BTD-001 (fasted)<br> | Drug: BTD-001<br>* BTD-001 in fed vs fasted state<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1 & Part 2 - Cmax of BTD-001 and major metabolites | Maximum Observed Plasma Concentration | [Maximum 30 days] | 
| Part 1 & Part 2 - Tmax of BTD-001 and major metabolites | Time to Maximum Observed Plasma Concentration | [Maximum 30 days] | 
| Part 1 & Part 2 - AUC(0-last): of BTD-001 and major metabolites | Area Under the Curve for Observed Plasma Concentration | [Maximum 30 days] | 
| Part 1 & Part 2 - T1/2 of BTD-001 and major metabolites | elimination half-life | [Maximum 30 days] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Examination | Safety and tolerability of BTD-001 by assessing physical examination | [Maximum 30 days] | 
| Vital Signs | Safety and tolerability of BTD-001 by assessing vital signs | [Maximum 30 days] | 
| ECG | Safety and tolerability of BTD-001 by assessing ECG | [Maximum 30 days] | 
| Adverse Events | Safety and tolerability of BTD-001 by assessing AEs | [Maximum 30 days] | 
| Safety Lab Test | Safety and tolerability of BTD-001 by assessing safety lab tests | [Maximum 30 days] | 
| Likert Scales | To assess BTD-001 withdrawal in healthy volunteers | [Maximum 30 days] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Effect, Pharmacokinetics