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

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ClinicalTrials.gov Identifier: NCT01899846
Recruitment Status : Completed
First Posted : July 16, 2013
Last Update Posted : August 18, 2014
Sponsor:
Information provided by (Responsible Party):
Lumara Health, Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pregnancy Drug: Hydroxyprogesterone caproate 250 mg/ml Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : July 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


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:
  • Makena
  • 17P

Experimental: Cohort 2
Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 24 - 28 weeks gestation
Drug: Hydroxyprogesterone caproate 250 mg/ml
Other Names:
  • Makena
  • 17P

Experimental: Cohort 3
Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 32 - 36 weeks gestation
Drug: Hydroxyprogesterone caproate 250 mg/ml
Other Names:
  • Makena
  • 17P




Primary Outcome Measures :
  1. Plasma concentrations of hydroxyprogesterone caproate and metabolites [ Time Frame: First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation ]

Secondary Outcome Measures :
  1. Plasma concentrations of hydroxyprogesterone caproate and metabolites [ Time Frame: Up to 28 days following last dose given in week 36 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899846


Locations
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United States, Florida
Altus Research, Inc.
Lake Worth, Florida, United States, 33461
United States, Idaho
Rosemark WomenCare Specialists
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Northwestern University Department of Obstetrics and Gynecology
Chicago, Illinois, United States, 60611
United States, North Carolina
University of North Carolina at Chapel Hill Hospital
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27710
United States, Wisconsin
The University of Wisconsin
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
Lumara Health, Inc.
Investigators
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Study Director: Robert Birch, PhD Lumara Health, Inc.

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Responsible Party: Lumara Health, Inc.
ClinicalTrials.gov Identifier: NCT01899846     History of Changes
Other Study ID Numbers: HPC-PK-005
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014
Keywords provided by Lumara Health, Inc.:
Makena
Pharmacokinetics
Prior preterm delivery
Hydroxyprogesterone Caproate
17P
Additional relevant MeSH terms:
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17 alpha-Hydroxyprogesterone Caproate
11-hydroxyprogesterone
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins
Hormones