A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm Study of the Safety, Tolerability and Pharmacokinetics of Oral BTD-001 in Healthy Volunteers

Phase 1

Completed

• Conditions: Cognitive impairment; Neurological - Neurodegenerative diseases

• Registration Number: ACTRN12613000919718
• Lead Sponsor: Balance Therapeutics Pty Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Healthy males and females as determined by medical history and physical examination between 18 and 35 years of age;
2. Written informed consent from the subject;
3. Able to comply with requirements for concomitant medications and consumption of caffeine, alcohol, tobacco and nicotine;
4. For females of child bearing potential, start date of their last menstrual period must be within 28 days of Day 1, first dose of study drug;
5. Sexually active females of childbearing potential must be willing to use a highly effective method of birth control from start of Screening until at least 3 months after last dose of study drug [defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, or some intrauterine contraceptive devices (IUDs);
-female partners of male study participants must use one of the following methods: Barrier contraceptive (e.g., female condom, cervical cap, diaphragm); Hormonal (oral, injectable, transdermal patch); or Intrauterine device; AND
-male participants must use condoms.

Exclusion Criteria

1. Weight <50 kg or > 110 kg;
2. BMI <18 kg/m2 or >35 kg/m2;
3. History of epilepsy, generalized convulsion or focal seizure (with exception of a single febrile seizure prior to 5 years of age);
4. Clinically significant (i.e., requiring medication or psychotherapy) psychiatric condition within the 2 years prior to Day 1, including but not limited to depression, bipolar disorder, generalized anxiety disorder, phobic disorders, panic disorder;
5. History of suicide attempt at any time, or of suicidal thinking within the last 6 months or behavior within the last 5 years reported on Screening Columbia Suicide Severity Rating Scale;
6. Personal or family history of congenital long QT syndrome or sudden death;
7. History of or current clinically significant or unstable neurological, psychiatric, cardiovascular, pulmonary, peripheral vascular, gastrointestinal, hepatic, endocrinological, hematological, or immunological conditions;
8. Any condition possibly affecting drug absorption (e.g., gastrectomy, vagotomy, or bowel resection);
9. Estimated glomerular filtration rate (eGFR) <90 mL/min by Cockroft Gault) at Screening or Baseline;
10. Screening or Baseline systolic blood pressure > 160 mm Hg or a diastolic blood pressure > 90 mm Hg (sitting or supine). One repeat measure is allowed to confirm eligibility;
11. Clinically significant abnormal electrocardiogram (ECG) at Screening or Baseline;
12. Clinically significant abnormalities in laboratory test results at Screening or Baseline;
13. Breastfeeding or pregnancy (females only);
14. Treatment with an investigational drug or biologic within 60 days preceding Day 1 (the first dose of study medication) or plans to take another investigational drug or biologic within 30 days of study completion;
15. Flu vaccination within 14 days of Day 1;
16. Blood donation or significant blood loss within 60 days prior to Day 1;
17. Plasma donation within 7 days of Day 1;
18. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified