Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02846142 · ClinicalTrials.gov registry record · Phase 1
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 of Healthy Volunteer, sponsored by Proteostasis Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 94
- Enrollment target
- 1
- Study location
NCT02846142 is a Phase 1 study of Healthy Volunteer that has completed, run by Proteostasis Therapeutics. The registered enrollment target is 94 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02846142, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Proteostasis Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 94 participants
- Enrollment target
- 1
- Study location
Study 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. 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 Studied
Interventions
- OTHER Placebo
- DRUG PTI-428
- DRUG ethinyl estradiol and levonorgestrel
Study Locations (1)
Kansas
- - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2016-06 |
| Est. Completion | 2017-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02846142
The ClinicalTrials.gov registry entry for NCT02846142 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (53% lower). The listed sponsor is Proteostasis Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02846142 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.
Frequently Asked Questions
What is clinical trial NCT02846142 about?
NCT02846142 is a clinical study titled "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". 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 e...
What is the current status of trial NCT02846142?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2016-06. Estimated completion is 2017-03.
What conditions does trial NCT02846142 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT02846142?
The interventions under investigation include: Placebo (OTHER), PTI-428 (DRUG), ethinyl estradiol and levonorgestrel (DRUG).
Who is sponsoring clinical trial NCT02846142?
This trial is sponsored by Proteostasis Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02846142 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Healthy Volunteer Study
RECRUITING · Phase 1
-
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
RECRUITING · Phase 1
-
Role of Metal Ion Transporter ZIP8 in Alcohol-Related Behaviors
RECRUITING · Phase 1
-
A First-in-Human Single and Multiple Ascending Dose Study of MT-201
RECRUITING · Phase 1
-
A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants
RECRUITING · Phase 1
-
A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.