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

Lumara Health

Status and phase

Completed

Phase 1

Conditions

Pregnancy

Treatments

Drug: Hydroxyprogesterone caproate 250 mg/ml

Study type

Interventional

Funder types

Industry

Identifiers

NCT01899846

HPC-PK-005

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.