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

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Altus Research, Inc., Lake Worth, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydroxyprogesterone caproate 250 mg/ml

Drug

Other names: Makena, 17P

Primary outcomes

Plasma concentrations of hydroxyprogesterone caproate and metabolites

Time frame: First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation

Secondary outcomes

Plasma concentrations of hydroxyprogesterone caproate and metabolites

Time frame: Up to 28 days following last dose given in week 36

Sponsors and collaborators

Lead sponsor

Lumara Health, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jul 16, 2013
Registry last updated: Aug 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed