Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood
- Registration Number
- NCT01899846
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- Age ≥ 18 years.
- Singleton gestation.
- Gestational age 16 weeks 0 days to 20 weeks 6 days.
- Previous singleton spontaneous preterm delivery
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 2 Hydroxyprogesterone caproate 250 mg/ml Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 24 - 28 weeks gestation Cohort 1 Hydroxyprogesterone caproate 250 mg/ml Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation following first dose Cohort 3 Hydroxyprogesterone caproate 250 mg/ml Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 32 - 36 weeks gestation
- Primary Outcome Measures
Name Time Method Plasma concentrations of hydroxyprogesterone caproate and metabolites First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation
- Secondary Outcome Measures
Name Time Method Plasma concentrations of hydroxyprogesterone caproate and metabolites Up to 28 days following last dose given in week 36
Trial Locations
- Locations (6)
Altus Research, Inc.
🇺🇸Lake Worth, Florida, United States
The University of Wisconsin
🇺🇸Madison, Wisconsin, 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