Clinical trial NCT01899846: Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pregnancy
Keywords: Makena
Pharmacokinetics
Prior preterm delivery
Hydroxyprogesterone Caproate
17P
Lead sponsor: Lumara Health, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Plasma concentrations of hydroxyprogesterone caproate and metabolites
timeFrame: First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation
Secondary outcomes:
measure: Plasma concentrations of hydroxyprogesterone caproate and metabolites
timeFrame: Up to 28 days following last dose given in week 36
Other outcomes:
Locations:
city: Lake Worth
country: United States
facility: Altus Research, Inc.
state: Florida
city: Idaho Falls
country: United States
facility: Rosemark WomenCare Specialists
state: Idaho
city: Chicago
country: United States
facility: Northwestern University Department of Obstetrics and Gynecology
state: Illinois
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Madison
country: United States
facility: The University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Lumara Health, Inc.
name: Robert Birch, PhD
role: STUDY_DIRECTOR
References: