Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine a safe and effective dose range for intravenous administration (infusion) of PDC31 by determining the maximum tolerated dose of PDC31 in patients with primary dysmenorrhea.

Detailed Description
-----------------
This is an open-label, multi-centre, dose-escalating first-in-human Phase I study of PDC31 in patients with primary dysmenorrhea aimed at determining the maximum tolerated dose (MTD) of PDC31 in this patient population.

Official Title
-----------------
A Dose-Escalating Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PDC31 in Patients With Primary Dysmenorrhea

Conditions
-----------------
Dysmenorrhea

Intervention / Treatment
-----------------
* Drug: PDC31


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Otherwise healthy females with a history of primary dysmenorrhea Using effective birth control excluding intrauterine contraceptive device (IUCD) Must be 18 years of age or older Must give written informed consent to participate in this study Exclusion Criteria: Patients with an intrauterine contraceptive device or using oral contraceptives within 3 months of treatment in this study Patients with confirmed pelvic inflammatory disease, endometriosis or adenomyosis Patients who are pregnant or who test positive at baseline or are at risk of becoming pregnant while on study Patients who are breastfeeding Patients with hepatic or renal function tests greater than the upper limit of normal and deemed clinically significant by the Investigator at screening Patients with a clinically significant medical or psychiatric disorder or a serious medical conditions within the past 6 months which in the opinion of the investigator, should prohibit participation in this study Patients who have been exposure to any investigational drug within 4 weeks prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDC31<br> | Drug: PDC31<br>* This study involves the sequential administration of PDC31 to 4 cohorts of patients. The dose will be escalated in the absence of dose-limiting toxicities. PDC31 is to be administered as a 3-hour continuous infusion.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Dose-Limiting Toxicity |  | Observed following PDC31 administration to 30 day follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility |  | Observed immediately following PDC31 administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open label, dose-finding Phase 1 study