CompletedPhase 1ACTRN12619000437167

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

A Study to Evaluate the Effect of AB-506 on the Single Dose Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects


Sponsor

Arbutus Biopharma Corporation

Enrollment

32 participants

Start Date

May 16, 2019

Study Type

Interventional

Conditions

Summary

The study will evaluate the effect of the study drug, AB-506, on the single dose pharmacokinetics of an oral contraceptive in healthy female participants. The duration of the study will be approximately 7 weeks, including the screening period.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria7

  • 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.
  • 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.
  • Body mass index (BMI) >/=18 kg/m2 and < /=30 kg/m2.
  • 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 Criteria9

  • Medical Status or History
  • 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.
  • Positive pregnancy test at Screening or Day -1.
  • 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.
  • Participation in an investigational drug, vaccine, or medical device study within 30 days before study drug administration, or 90 days for a biologic study.
  • 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.
  • Clinically significant ECG abnormalities prior to dosing (screening or day -1) that are confirmed by a repeat reading.
  • Clinically significant abnormalities in laboratory test results at screening or day -1 that are confirmed by a repeat reading.
  • 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.

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Interventions

This study will consist of 2 treatment periods. A popular choice among women of child-bearing potential is a monophasic oral contraceptive combination containing a fixed dose of 3 mg drospirenone (DRS

This study will consist of 2 treatment periods. A popular choice among women of child-bearing potential is a monophasic oral contraceptive combination containing a fixed dose of 3 mg drospirenone (DRSP) and 0.02 mg ethinyl estradiol (EE). The study will be conducted in approximately 32 subjects. In Period 1, healthy female subjects will receive a single dose of DRSP/EE on Day 1, administered as oral tablet, followed by a washout of 5 days. In Period 2, subjects will receive AB-506 400 mg, administered as oral tablet, once daily for 13 days, with a single oral dose of DRSP/EE (same dose as Day 1) co-administered on Day 15. The duration of the study will be approximately 7 weeks, including the screening period. Subjects will take their study drug in the presence of study staff. Compliance will be confirmed by a mouth check after dosing.


Locations(1)

Nucleus Network - Melbourne

VIC, Australia

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ACTRN12619000437167