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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE July 11, 2013
First Posted Date  ICMJE July 16, 2013
Last Update Posted Date August 18, 2014
Study Start Date  ICMJE July 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
Plasma concentrations of hydroxyprogesterone caproate and metabolites [ Time Frame: First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2013)
Plasma and urine concentrations of hydroxyprogesterone caproate and metabolites [ Time Frame: First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
Plasma concentrations of hydroxyprogesterone caproate and metabolites [ Time Frame: Up to 28 days following last dose given in week 36 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2013)
Plasma and urine concentrations of hydroxyprogesterone caproate and metabolites [ Time Frame: Up to 28 days following last dose given in week 36 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Pregnancy
Intervention  ICMJE Drug: Hydroxyprogesterone caproate 250 mg/ml
Other Names:
  • Makena
  • 17P
Study Arms  ICMJE
  • Experimental: Cohort 1
    Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation following first dose
    Intervention: Drug: Hydroxyprogesterone caproate 250 mg/ml
  • Experimental: Cohort 2
    Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 24 - 28 weeks gestation
    Intervention: Drug: Hydroxyprogesterone caproate 250 mg/ml
  • Experimental: Cohort 3
    Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 32 - 36 weeks gestation
    Intervention: Drug: Hydroxyprogesterone caproate 250 mg/ml
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01899846
Other Study ID Numbers  ICMJE HPC-PK-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Lumara Health, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Lumara Health, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Birch, PhD Lumara Health, Inc.
PRS Account Lumara Health, Inc.
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP