Study to Assess the Safety, Tolerability, PK, ECG Effects, Food Effect, and Drug-drug Interaction (DDI) of Hormonal Contraceptives of PTI-428 in Healthy Female Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 5/26/2018 |
| Start Date: | June 2016 |
| End Date: | March 2017 |
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.
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.
Inclusion Criteria:
- Adult females age 18 - 55 years old, inclusive, at the time of informed consent.
- For the DDI Oral Contraceptive Cohort, women of child bearing potential with intact
ovarian function by medical history and history of regular menstrual. cycles.
- Body mass index (BMI) ≥18 < 30 kg/m2.
- Subject must be non-smoker and non-tobacco user for a minimum of 30 days prior to
screening and for the duration of the study.
- Subject understands the full nature and purpose of the study, including possible risks
and side effects, and is willing and able to comply with all compulsory study
procedures and provides informed consent/permission prior to any study procedures
being performed.
Exclusion Criteria:
- History or current evidence of any clinically significant cardiac, endocrinologic,
hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic,
dermatologic, psychiatric, renal, or other major disease, as determined by the
Investigator.
- Abnormal liver function as defined by:
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or bilirubin > 1.5 x
upper limit of the normal range.
- Abnormal renal function at screening defined as:
- Creatinine clearance < 80mL/min using the Cockroft-Gault equation.
- No clinically significant screening results that would exclude subject from the study
(e.g., medical histories, physical examination, ECGs, vital signs,and laboratory
profiles) as deemed by the investigator.
- Platelet count < 150,000 cell/mm3
- Participation in another clinical trial or treatment with an investigational agent
within 30 days or 5 half-lives, whichever is longer, prior to Study Day 1.
- History of cancer within the past five years (excluding non-melanoma skin cancer).
- History of alcohol or drug abuse or dependence within 12 months of screening as
determined by the Investigator.
- Positive urine screen for prohibited drugs (cocaine, cannabinoids, nicotine [urine
cotinine is the detection mechanism for nicotine], opiates, barbiturates,
amphetamines, and benzodiazepines) or positive alcohol test at screening.
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface
antigen (HBsAg), or hepatitis C virus antibody (HCVAb).
- Clinically significant infection within 3 months of screening as determined by the
Investigator.
- Known or suspected hypersensitivity or idiosyncratic reaction to study medication or
any components thereof.
- Has donated blood within 3 months of screening or plans to donate blood within 3
months of study completion.
- Pregnant or nursing women.
- Any conditions that, in the opinion of the Investigator, would make the subject
unsuitable for enrollment or could interfere with the subject's participation in or
completion of the study.
- Females of child-bearing potential, unless they are willing to use highly effective
methods of contraception during participation in the clinical study and for 30 days
after termination from study.
- Use of prohibited medications within 14 days prior to dosing of study drug.
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