A study to investigate the effect of AB-506 on Single Dose Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects

Phase 1

Completed

• Conditions: Chronic Hepatitis B Infection (CHB); Infection - Other infectious diseases; Reproductive Health and Childbirth - Contraception

• Registration Number: ACTRN12619000437167
• Lead Sponsor: Arbutus Biopharma Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Study Completion: 2019-07-08
• Last Update Posted: 22 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

1. Healthy females aged 18–50, inclusive. Healthy subjects are defined as individuals free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, and clinical laboratory test results.
2. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
i. Not a WOCBP
OR
ii. A WOCBP who agrees to using a non-hormonal contraceptive at least 4 weeks prior to the first dose of the study, during the study, and 30 days after the last dose is administered. Subject should be willing to use acceptable forms of non-hormonal contraceptives.
3. Body mass index (BMI) >/=18 kg/m2 and < /=30 kg/m2.
4. Capable of giving signed informed consent; able to understand and comply with protocol requirements, instructions, and protocol-related restrictions; and likely to complete the study as planned.

Exclusion Criteria

Medical Status or History
1. Any known pre-existing medical or psychiatric condition that could interfere with the subject’s ability to provide informed consent or participate in study conduct, or that may confound study findings including, but not limited to a history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, or cardiovascular disease.
2. Positive pregnancy test at Screening or Day -1.
3. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
4. Participation in an investigational drug, vaccine, or medical device study within 30 days before study drug administration, or 90 days for a biologic study.
5. Any known or suspected hypersensitivity or previous severe reactions to any of the constituents of AB-506 or oral contraceptives, or history of any other allergy that, in the opinion of the Investigator, contraindicates participation in the trial.
6. Clinically significant ECG abnormalities prior to dosing (screening or day -1) that are confirmed by a repeat reading.
7. Clinically significant abnormalities in laboratory test results at screening or day -1 that are confirmed by a repeat reading.
8. Abnormal blood pressure at Screening, Day -1, or Day 1 pre-dose that is confirmed by a repeat reading and assessed as clinically significant by the Investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified