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

• Sponsor: Balance Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03150498
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Food Effect; Healthy	Drug: BTD-001	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: May 3, 2017
• Actual Primary Completion Date: Jul 12, 2017
• Actual Study Completion Date: Jul 12, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Part 1 & Part 2 - Cmax of BTD-001 and major metabolites [[Maximum 30 days]]

   Maximum Observed Plasma Concentration

2. Part 1 & Part 2 - Tmax of BTD-001 and major metabolites [[Maximum 30 days]]

   Time to Maximum Observed Plasma Concentration

3. Part 1 & Part 2 - AUC(0-last): of BTD-001 and major metabolites [[Maximum 30 days]]

   Area Under the Curve for Observed Plasma Concentration

4. Part 1 & Part 2 - T1/2 of BTD-001 and major metabolites [[Maximum 30 days]]

   elimination half-life

Secondary Outcome Measures

1. Physical Examination [[Maximum 30 days]]

   Safety and tolerability of BTD-001 by assessing physical examination

2. Vital Signs [[Maximum 30 days]]

   Safety and tolerability of BTD-001 by assessing vital signs

3. ECG [[Maximum 30 days]]

   Safety and tolerability of BTD-001 by assessing ECG

4. Adverse Events [[Maximum 30 days]]

   Safety and tolerability of BTD-001 by assessing AEs

5. Safety Lab Test [[Maximum 30 days]]

   Safety and tolerability of BTD-001 by assessing safety lab tests

6. Likert Scales [[Maximum 30 days]]

   To assess BTD-001 withdrawal in healthy volunteers

Other Outcome Measures

1. Karolinska Sleepiness Scale [[Maximum 30 days]]

   To assess sleepiness using the KSS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Clinical	Ruddington	Nottingham	United Kingdom	NG11 6JS

Sponsors and Collaborators

• Balance Therapeutics

Investigators

• Principal Investigator: Nand Signh, MD, Quotient Clinical Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Balance Therapeutics
• ClinicalTrials.gov Identifier: NCT03150498
• Other Study ID Numbers: BTD-001 HV104
• First Posted: May 12, 2017
• Last Update Posted: Oct 24, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Balance Therapeutics: Food Effect; Pharmacokinetics

Study Results

No Results Posted as of Oct 24, 2017