Healthy Volunteer Clinical Trial
Official title:
A Single-center, Randomized, Placebo-Controlled Phase I Study Designed to Assess the Safety, Tolerability, Pharmacokinetics, ECG Effects, Food Effect, and Drug-drug Interaction (DDI) of Hormonal Contraceptives of PTI-428 in Healthy Female Volunteers
This trial will consist of three parts: the first two parts will enroll healthy female
volunteers into a single ascending dose (SAD) and multiple ascending dose (MAD) treatment
groups.
The SAD treatment group is comprised of at least 3 cohorts where subjects will be randomized
to a single dose of either PTI-428 or placebo and will be followed for 7 days post dose. A
total of 24 subjects are anticipated to participate in this part of the study.
Following the conclusion of the respective SAD level dose groups and after sufficient review
of study data and approval by the SRC, a second set of healthy adult female subjects will
participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3
cohorts where subjects will be randomized to either PTI-428 or placebo and will be followed
for a total of 14 days. The SRC will convene after the completion of each cohort to evaluate
safety, PK and other relevant data. The SRC will determine whether to proceed to the next
planned dose level, to reduce the dose, or to stop the study. The next cohort may commence
only after written SRC approval. A total of 24 subjects are anticipated to participate in
this part of the study.
Following completion of the SAD and MAD, 40 female healthy volunteers will participate in two
treatment periods of the DDI study component: Treatment period A will consist of once daily
oral contraceptive (OC) for 28-days (21-day hormonal active + 7 days off).
Treatment period B will randomize subjects to PTI-428 or placebo in combination with once
daily OC for 28 days (21-day hormonal active and PTI-428 or placebo + 7 days off). Following
completion of the subjects' second treatment period, they will be followed for 7-days after
their last dose.
n/a
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