Overview

This trial is active, not recruiting.

Condition pregnancy
Treatment hydroxyprogesterone caproate 250 mg/ml
Phase phase 1
Sponsor Lumara Health, Inc.
Start date July 2013
End date July 2014
Trial size 30 participants
Trial identifier NCT01899846, HPC-PK-005

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation following first dose
hydroxyprogesterone caproate 250 mg/ml Makena
(Experimental)
Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 24 - 28 weeks gestation
hydroxyprogesterone caproate 250 mg/ml Makena
(Experimental)
Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 32 - 36 weeks gestation
hydroxyprogesterone caproate 250 mg/ml Makena

Primary Outcomes

Measure
Plasma concentrations of hydroxyprogesterone caproate and metabolites
time frame: First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation

Secondary Outcomes

Measure
Plasma concentrations of hydroxyprogesterone caproate and metabolites
time frame: Up to 28 days following last dose given in week 36

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Lumara Health, Inc..