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

Completed · Phase 1

Conditions studied: Pregnancy

In brief

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.

Key facts

Study ID

NCT01899846

Run by

Lumara Health, Inc.

People needed

30

Starts

2013-07-01

Expected to finish

2014-08-01

Last updated by the study team

2014-08-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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