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

Balance Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy

Food Effect

Treatments

Drug: BTD-001

Study type

Interventional

Funder types

Industry

Identifiers

NCT03150498

BTD-001 HV104

Details and patient eligibility

About

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

Enrollment

12 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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