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

NCT01899846 | Completed Phase 1

• 1 other identifier: HPC-PK-005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

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.

Conditions

Pregnancy

Keywords

Makena; Pharmacokinetics; Prior preterm delivery; Hydroxyprogesterone Caproate; 17P

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of hydroxyprogesterone caproate and metabolites

  First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation

Secondary Outcomes (1)

• Plasma concentrations of hydroxyprogesterone caproate and metabolites

  Up to 28 days following last dose given in week 36

Study Arms (3)

Cohort 1

EXPERIMENTAL

Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation following first dose

Drug: Hydroxyprogesterone caproate 250 mg/ml

Cohort 2

EXPERIMENTAL

Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 24 - 28 weeks gestation

Drug: Hydroxyprogesterone caproate 250 mg/ml

Cohort 3

EXPERIMENTAL

Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 32 - 36 weeks gestation

Drug: Hydroxyprogesterone caproate 250 mg/ml

Interventions

Hydroxyprogesterone caproate 250 mg/ml DRUG

Also known as: Makena, 17P

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Singleton gestation.
• Gestational age 16 weeks 0 days to 20 weeks 6 days.
• Previous singleton spontaneous preterm delivery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lumara Health, Inc.: lead

Study Sites (6)

Altus Research, Inc.

Lake Worth, Florida, 33461, United States

Location

Rosemark WomenCare Specialists

Idaho Falls, Idaho, 83404, United States

Location

Northwestern University Department of Obstetrics and Gynecology

Chicago, Illinois, 60611, United States

Location

University of North Carolina at Chapel Hill Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

The University of Wisconsin

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Interventions

17 alpha-Hydroxyprogesterone Caproate

Intervention Hierarchy (Ancestors)

17-alpha-Hydroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Robert Birch, PhD

  Lumara Health, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 16, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 18, 2014

Record last verified: 2014-08

Locations

US (6)