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NCT01899846 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Pregnancy, sponsored by Lumara Health.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
6
Study locations

NCT01899846 is a Phase 1 study of Pregnancy that has completed, run by Lumara Health. The registered enrollment target is 30 participants, below the 873-participant average among 191 other Pregnancy trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT01899846, a Phase 1 study of Pregnancy, has completed, sponsored by Lumara Health.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
6
Study locations

Study 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 Studied

Pregnancy

Interventions

  • DRUG Hydroxyprogesterone caproate 250 mg/ml

Study Locations (6)

North Carolina

  • University of North Carolina at Chapel Hill Hospital - Chapel Hill
  • Duke University - Durham

Florida

  • Altus Research, Inc. - Lake Worth

Idaho

  • Rosemark WomenCare Specialists - Idaho Falls

Illinois

  • Northwestern University Department of Obstetrics and Gynecology - Chicago

Wisconsin

  • The University of Wisconsin - Madison

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2013-07
Est. Completion 2014-08
Phase Phase 1

Sponsor

Lumara Health

6 total trials

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What the Registry Record Tells You About NCT01899846

The ClinicalTrials.gov registry entry for NCT01899846 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 873-participant average among 191 other Pregnancy trials with a reported enrollment target (97% lower). The listed sponsor is Lumara Health, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which Hydroxyprogesterone caproate 250 mg/ml is the first listed.

NCT01899846 reports 6 study locations spanning 5 distinct geographic areas - top geographies include North Carolina, Florida, Idaho.

Frequently Asked Questions

What is clinical trial NCT01899846 about?

NCT01899846 is a clinical study titled "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 dos...

What is the current status of trial NCT01899846?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2013-07. Estimated completion is 2014-08.

What conditions does trial NCT01899846 study?

This clinical trial studies the following conditions: Pregnancy.

What interventions are being tested in trial NCT01899846?

The interventions under investigation include: Hydroxyprogesterone caproate 250 mg/ml (DRUG).

Who is sponsoring clinical trial NCT01899846?

This trial is sponsored by Lumara Health, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01899846 being conducted?

This trial has 6 study locations across Florida, Idaho, Illinois, North Carolina, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.