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

NCT03150498 | Completed Phase 1 FDA Drug

• 1 other identifier: BTD-001 HV104
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Food Effect; Healthy

Keywords

Food Effect; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Physical Examination

  [Maximum 30 days]

• Vital Signs

  [Maximum 30 days]

• ECG

  [Maximum 30 days]

• Adverse Events

  [Maximum 30 days]

• Safety Lab Test

  [Maximum 30 days]

Other Outcomes (1)

• Karolinska Sleepiness Scale

  [Maximum 30 days]

Study Arms (2)

BTD-001 (fed)

EXPERIMENTAL

Drug: BTD-001

BTD-001 (fasted)

EXPERIMENTAL

Drug: BTD-001

Interventions

BTD-001 DRUG

BTD-001 in fed vs fasted state

BTD-001 (fasted); BTD-001 (fed)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Balance Therapeutics: lead

Study Sites (1)

Quotient Clinical

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Nand Signh, MD

  Quotient Clinical Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 12, 2017
• Study Start: May 3, 2017
• Primary Completion: July 12, 2017
• Study Completion: July 12, 2017
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

GB (1)