Clinical trial NCT03150498: A Food Effects Study and Optional Multi Dose Study to Assess PK of BTD-001
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Food Effect
Healthy
Keywords: Food Effect
Pharmacokinetics
Lead sponsor: Balance Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-05-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Part 1 & Part 2 - Cmax of BTD-001 and major metabolites
timeFrame: [Maximum 30 days]
measure: Part 1 & Part 2 - Tmax of BTD-001 and major metabolites
timeFrame: [Maximum 30 days]
measure: Part 1 & Part 2 - AUC(0-last): of BTD-001 and major metabolites
timeFrame: [Maximum 30 days]
measure: Part 1 & Part 2 - T1/2 of BTD-001 and major metabolites
timeFrame: [Maximum 30 days]
Secondary outcomes:
measure: Physical Examination
timeFrame: [Maximum 30 days]
measure: Vital Signs
timeFrame: [Maximum 30 days]
measure: ECG
timeFrame: [Maximum 30 days]
measure: Adverse Events
timeFrame: [Maximum 30 days]
measure: Safety Lab Test
timeFrame: [Maximum 30 days]
measure: Likert Scales
timeFrame: [Maximum 30 days]
Other outcomes:
measure: Karolinska Sleepiness Scale
timeFrame: [Maximum 30 days]
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Clinical
state: Nottingham
Study officials:
affiliation: Quotient Clinical Ltd
name: Nand Signh, MD
role: PRINCIPAL_INVESTIGATOR
References: