Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood and Urine
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | July 2013 |
| End Date: | April 2014 |
| Contact: | Robert Birch, PhD |
| Email: | rbirch@ther-rx.com |
| Phone: | 314-645-6600 |
A Multi-Center, Non-Randomized Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood and Urine 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 and urine throughout pregnancy
There will be 3 cohorts of subjects
Cohort 1 (6 subjects) will have daily urine samples collected and blood draws in the morning
at approximately the same time each day for one week following their first dose of Makena
and will have a urine sample collected and 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 a urine sample collected and blood drawn to determine the
trough concentration 7 days after their first dose of Makena. Subjects will have daily
urine samples collected and blood draws for one week following a dose of Makena given in
Epoch 1 (24 - 28 weeks) and a urine sample collected and blood drawn immediately prior to 2
successive doses during Epoch 2 (32 - 36 weeks)
Cohort 3 (16 subjects) will have a urine sample collected and blood drawn to determine the
trough concentration 7 days after their first dose of Makena. Subjects will have a urine
sample collected and blood drawn immediately prior to 2 successive doses in Epoch 1 (24 -
28 weeks) and a daily urine sample collected and 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.
blood and urine throughout pregnancy
There will be 3 cohorts of subjects
Cohort 1 (6 subjects) will have daily urine samples collected and blood draws in the morning
at approximately the same time each day for one week following their first dose of Makena
and will have a urine sample collected and 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 a urine sample collected and blood drawn to determine the
trough concentration 7 days after their first dose of Makena. Subjects will have daily
urine samples collected and blood draws for one week following a dose of Makena given in
Epoch 1 (24 - 28 weeks) and a urine sample collected and blood drawn immediately prior to 2
successive doses during Epoch 2 (32 - 36 weeks)
Cohort 3 (16 subjects) will have a urine sample collected and blood drawn to determine the
trough concentration 7 days after their first dose of Makena. Subjects will have a urine
sample collected and blood drawn immediately prior to 2 successive doses in Epoch 1 (24 -
28 weeks) and a daily urine sample collected and 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.
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.
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