Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood

August 14, 2014 updated by: Lumara Health, Inc.

A Multi-Center, Non-Randomized Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood of Women With a Singleton Pregnancy and a Previous Singleton Spontaneous Preterm Delivery

This study will evaluate the levels of hydroxyprogesterone caproate and it's metabolites in blood throughout pregnancy

There will be 3 cohorts of subjects

Cohort 1 (6 subjects) will have daily blood draws in the morning at approximately the same time each day for one week following their first dose of Makena and will have blood drawn immediately prior to 2 successive Makena doses during Epoch 1 (24 - 28 weeks) and Epoch 2 (32 - 36 weeks)

Cohort 2 (8 subjects) will have blood drawn to determine the trough concentration 7 days after their first dose of Makena. Subjects will have daily blood draws for one week following a dose of Makena given in Epoch 1 (24 - 28 weeks) and blood drawn immediately prior to 2 successive doses during Epoch 2 (32 - 36 weeks)

Cohort 3 (16 subjects) will have blood drawn to determine the trough concentration 7 days after their first dose of Makena. Subjects will have blood drawn immediately prior to 2 successive doses in Epoch 1 (24 - 28 weeks) and daily blood draws for one week following a dose of Makena given during Epoch 2 (32 - 36 weeks)

A maximum of 10 subjects will be monitored on selected days following a completed course of Makena therapy to determine the terminal elimination phase.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Lake Worth, Florida, United States, 33461
        • Altus Research, Inc.
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rosemark WomenCare Specialists
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Department of Obstetrics and Gynecology
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill Hospital
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • The University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Singleton gestation.
  • Gestational age 16 weeks 0 days to 20 weeks 6 days.
  • Previous singleton spontaneous preterm delivery

Exclusion Criteria:

  • Multifetal gestation.
  • Known major fetal anomaly or fetal demise.
  • Progestin treatment in any form in the 4 weeks prior to study entry.
  • Heparin therapy during current pregnancy or history of thromboembolic disease.
  • Maternal medical/obstetrical complications including hypertension requiring medication or seizure disorder.
  • uterine anomaly other than fibroids
  • Known hypersensitivity to hydroxyprogesterone caproate injection or its components.
  • Any significant medical disorder that, in the opinion of the investigator, would be a contraindication to the use of the drug or would preclude accurate evaluation of the subject's condition or outcome or compromise the subject's safety in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation following first dose
Drug: Hydroxyprogesterone caproate 250 mg/ml
Other Names:
  • 17P
  • Makena
Experimental: Cohort 2
Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 24 - 28 weeks gestation
Drug: Hydroxyprogesterone caproate 250 mg/ml
Other Names:
  • 17P
  • Makena
Experimental: Cohort 3
Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 32 - 36 weeks gestation
Drug: Hydroxyprogesterone caproate 250 mg/ml
Other Names:
  • 17P
  • Makena

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentrations of hydroxyprogesterone caproate and metabolites
Time Frame: First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation
First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentrations of hydroxyprogesterone caproate and metabolites
Time Frame: Up to 28 days following last dose given in week 36
Up to 28 days following last dose given in week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumara Health, Inc.

Investigators

  • Study Director: Robert Birch, PhD, Lumara Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

July 11, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (Estimate)

July 16, 2013

Study Record Updates

Last Update Posted (Estimate)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 14, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPC-PK-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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