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

Pregnancy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899846
• Other study ID #: HPC-PK-005
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2013
• Last updated: August 14, 2014
• Start date: July 2013
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Lumara Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Hydroxyprogesterone caproate 250 mg/ml

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Lumara Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of hydroxyprogesterone caproate and metabolites		First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation	No
Secondary	Plasma concentrations of hydroxyprogesterone caproate and metabolites		Up to 28 days following last dose given in week 36	No