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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy; Food Effect
• Intervention / Treatment: Drug: BTD-001

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Ruddington, Nottingham, United Kingdom, NG11 6JS
      • Quotient Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BTD-001 (fed)	Drug: BTD-001; BTD-001 in fed vs fasted state
Experimental: BTD-001 (fasted)	Drug: BTD-001; BTD-001 in fed vs fasted state

What is the study measuring?

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]

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Karolinska Sleepiness Scale	To assess sleepiness using the KSS	[Maximum 30 days]

Collaborators and Investigators

• Sponsor: Balance Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Actual): July 12, 2017
• Study Completion (Actual): July 12, 2017

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 20, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Food Effect
• Other Study ID Numbers: BTD-001 HV104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No