Healthy VolunteerPhase 1NCT02846142

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

A Phase 1 study testing PTI-428 and ethinyl estradiol and levonorgestrel in people with Healthy Volunteer, run by Proteostasis Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: PTI-428 and ethinyl estradiol and levonorgestrel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 94 participants
Where: 1 siteUnited States
Study dates: Jun 2016to Mar 2017
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 19Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Overland Park, Kansas

Other trials in United States

About this study

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.

Conditions: Healthy Volunteer
Being tested: PTI-428, Placebo, ethinyl estradiol and levonorgestrel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PTI-428Drug
PlaceboOther
ethinyl estradiol and levonorgestrelDrug

Study groups in NCT02846142
Study group	Role	What they receive
SAD PTI-428	Active comparator	The safety, tolerability, and pharmacokinetic profile of PTI-428 will be evaluated following a single dose of PTI-428. Three cohorts are planned for evaluation where subjects will be randomized to PTI-428 or placebo.The subjects will be followed for 7 days post dose. Receives: Drug: PTI-428
SAD placebo	Placebo comparator	The safety, tolerability, and pharmacokinetic profile of PTI-428 will be evaluated following a single dose of PTI-428. Three cohorts are planned for evaluation where subjects will be randomized to PTI-428 or placebo.The subjects will be followed for 7 days post dose. Receives: Other: Placebo
MAD PTI-428	Active comparator	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. Subjects will be randomized to either PTI-428 or placebo. Each dose will be administered once daily (QD) for a total of 7 days. Follow up visits will occur on Days 12 and 14. Receives: Drug: PTI-428
MAD placebo	Placebo comparator	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. Subjects will be randomized to either PTI-428 or placebo. Each dose will be administered once daily (QD) for a total of 7 days. Follow up visits will occur on Days 12 and 14. Receives: Other: Placebo
OC (ethinyl estradiol and levonorgestrel) DDI Period A	Experimental	Treatment period A will consist of once daily oral contraceptive (OC) for 28-days (21-day hormonal active + 7 days off). Receives: Drug: ethinyl estradiol and levonorgestrel
OC (ethinyl estradiol and levonorgestrel) DDI Period B	Active comparator	Treatment period B will randomize subjects to PTI-428 or placebo in combination with once daily OC daily for 28 days (21-day hormonal active + 7 days off). Receives: Drug: PTI-428; Drug: ethinyl estradiol and levonorgestrel
OC (ethinyl estradiol and levonorgestrel) DDI	Placebo comparator	Treatment period B will randomize subjects 4:1 to PTI-428 or placebo in combination with once daily OC daily for 28 days (21-day hormonal active + 7 days off). Receives: Other: Placebo; Drug: ethinyl estradiol and levonorgestrel

What is being measured

The primary outcome is the main question the study is designed to answer.

SAD and MAD: Safety and tolerability measured by number of subjects who experience adverse events and potential clinically significant changes in safety labs, electrocardiograms (ECGs), physical examinations, and vital signs
Measured: baseline to 7 days
SAD: Apparent terminal half-life (t1/2) of single oral dose
Measured: through 72-hours post dose
SAD: Time to reach maximum plasma concentration (Tmax) of single oral dose
Measured: through 72-hours post dose
SAD: Maximum plasma concentration (Cmax) of single oral dose
Measured: through 72-hours post dose
SAD: Area under the concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) of single oral dose
Measured: through 72-hours post dose
MAD: Apparent terminal half-life (t1/2) of multiple oral doses
Measured: through 72 hours post day 7 dose
MAD: Time to reach maximum plasma concentration (Tmax) of multiple oral doses
Measured: through 72 hours post day 7 dose
MAD: Maximum plasma concentration (Cmax) of multiple oral doses
Measured: through 72 hours post day 7 dose
MAD: Area under the concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) of multiple oral doses
Measured: through 72 hours post day 7 dose
SAD: Cumulative amount of PTI-428 excreted unchanged in urine (Ae)
Measured: through 72-hours post dose
SAD: renal clearance (CLR)
Measured: through 72-hours post dose
MAD: Cumulative amount of PTI-428 excreted unchanged in urine (Ae)
Measured: through 72 hours post day 7 dose
MAD: renal clearance (CLR)
Measured: through 72 hours post day 7 dose
OC: Time to reach maximum plasma concentration (Tmax) of multiple oral doses
Measured: through day 49
OC: Maximum plasma concentration (Cmax) of multiple oral doses
Measured: through day 49
OC: Area under the concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) of multiple oral doses
Measured: through day 49

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Mar 2017

First posted27 Jul 2016 (estimated)
Study startJun 2016
Primary completionMar 2017
Study completionMar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02846142
Sponsor's protocol ID: PTI-428-02
Status last verified: May 2018
First submitted: 18 Jul 2016
Last updated: 24 May 2018
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02846142
Acronym / sponsor ID: PTI-428-02
Conditions: Healthy Volunteer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Proteostasis Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 27 Jul 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
SAD PTI-428	Active comparator	Drug: PTI-428The safety, tolerability, and pharmacokinetic profile of PTI-428 will be evaluated following a single dose of PTI-428. Three cohorts are planned for evaluation where subjects will be randomized to PTI-428 or placebo.The subjects will be followed for 7 days post dose.
SAD placebo	Placebo comparator	Other: PlaceboThe safety, tolerability, and pharmacokinetic profile of PTI-428 will be evaluated following a single dose of PTI-428. Three cohorts are planned for evaluation where subjects will be randomized to PTI-428 or placebo.The subjects will be followed for 7 days post dose.
MAD PTI-428	Active comparator	Drug: PTI-428Following 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. Subjects will be randomized to either PTI-428 or placebo. Each dose will be administered once daily (QD) for a total of 7 days. Follow up visits will occur on Days 12 and 14.
MAD placebo	Placebo comparator	Other: PlaceboFollowing 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. Subjects will be randomized to either PTI-428 or placebo. Each dose will be administered once daily (QD) for a total of 7 days. Follow up visits will occur on Days 12 and 14.
OC (ethinyl estradiol and levonorgestrel) DDI Period A	Experimental	Drug: ethinyl estradiol and levonorgestrelTreatment period A will consist of once daily oral contraceptive (OC) for 28-days (21-day hormonal active + 7 days off).
OC (ethinyl estradiol and levonorgestrel) DDI Period B	Active comparator	Drug: PTI-428, Drug: ethinyl estradiol and levonorgestrelTreatment period B will randomize subjects to PTI-428 or placebo in combination with once daily OC daily for 28 days (21-day hormonal active + 7 days off).
OC (ethinyl estradiol and levonorgestrel) DDI	Placebo comparator	Other: Placebo, Drug: ethinyl estradiol and levonorgestrelTreatment period B will randomize subjects 4:1 to PTI-428 or placebo in combination with once daily OC daily for 28 days (21-day hormonal active + 7 days off).

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PTI-428	Drug	MAD PTI-428, OC (ethinyl estradiol and levonorgestrel) DDI Period B, SAD PTI-428
Placebo	Other	MAD placebo, OC (ethinyl estradiol and levonorgestrel) DDI, SAD placebo
ethinyl estradiol and levonorgestrel	Drug	OC (ethinyl estradiol and levonorgestrel) DDI, OC (ethinyl estradiol and levonorgestrel) DDI Period A, OC (ethinyl estradiol and levonorgestrel) DDI Period B

Primary outcome

SAD and MAD: Safety and tolerability measured by number of subjects who experience adverse events and potential clinically significant changes in safety labs, electrocardiograms (ECGs), physical examinations, and vital signs
Time frame: baseline to 7 days
SAD: Apparent terminal half-life (t1/2) of single oral dose
Time frame: through 72-hours post dose
SAD: Time to reach maximum plasma concentration (Tmax) of single oral dose
Time frame: through 72-hours post dose
SAD: Maximum plasma concentration (Cmax) of single oral dose
Time frame: through 72-hours post dose
SAD: Area under the concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) of single oral dose
Time frame: through 72-hours post dose
MAD: Apparent terminal half-life (t1/2) of multiple oral doses
Time frame: through 72 hours post day 7 dose
MAD: Time to reach maximum plasma concentration (Tmax) of multiple oral doses
Time frame: through 72 hours post day 7 dose
MAD: Maximum plasma concentration (Cmax) of multiple oral doses
Time frame: through 72 hours post day 7 dose
MAD: Area under the concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) of multiple oral doses
Time frame: through 72 hours post day 7 dose
SAD: Cumulative amount of PTI-428 excreted unchanged in urine (Ae)
Time frame: through 72-hours post dose
SAD: renal clearance (CLR)
Time frame: through 72-hours post dose
MAD: Cumulative amount of PTI-428 excreted unchanged in urine (Ae)
Time frame: through 72 hours post day 7 dose
MAD: renal clearance (CLR)
Time frame: through 72 hours post day 7 dose
OC: Time to reach maximum plasma concentration (Tmax) of multiple oral doses
Time frame: through day 49
OC: Maximum plasma concentration (Cmax) of multiple oral doses
Time frame: through day 49
OC: Area under the concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) of multiple oral doses
Time frame: through day 49

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PTI-428 and ethinyl estradiol and levonorgestrel in people with Healthy Volunteer, run by Proteostasis Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SAD and MAD: Safety and tolerability measured by number of subjects who experience adverse events and potential clinically significant changes in safety labs, electrocardiograms (ECGs), physical examinations, and vital signs (time frame: baseline to 7 days). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02846142.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.