PregnancyPhase 1NCT01899846
Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood
A Phase 1 study testing Hydroxyprogesterone caproate 250 mg/ml in people with Pregnancy, run by Lumara Health, Inc. at 6 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Hydroxyprogesterone caproate 250 mg/ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2013to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Singleton gestation.
- Gestational age 16 weeks 0 days to 20 weeks 6 days.
- Previous singleton spontaneous preterm delivery
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of North Carolina at Chapel Hill Hospital
Chapel Hill, North Carolina, 27599
Northwestern University Department of Obstetrics and Gynecology
Chicago, Illinois, 60611
Duke University
Durham, North Carolina, 27710
Rosemark WomenCare Specialists
Idaho Falls, Idaho, 83404
Altus Research, Inc.
Lake Worth, Florida, 33461
The University of Wisconsin
Madison, Wisconsin, 53715
About this study
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
This study will evaluate the levels of hydroxyprogesterone caproate and it's metabolites in blood throughout pregnancy
There will be 3 cohorts of subjects
Read more
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
- Being tested
- Hydroxyprogesterone caproate 250 mg/ml
- Keywords
- Makena, Pharmacokinetics, Prior preterm delivery, Hydroxyprogesterone Caproate, 17P
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyprogesterone caproate 250 mg/mlDrug
Also called Makena, 17P
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation following first dose Receives: Drug: Hydroxyprogesterone caproate 250 mg/ml |
| Cohort 2 | Experimental | Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 24 - 28 weeks gestation Receives: Drug: Hydroxyprogesterone caproate 250 mg/ml |
| Cohort 3 | Experimental | Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 32 - 36 weeks gestation Receives: Drug: Hydroxyprogesterone caproate 250 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of hydroxyprogesterone caproate and metabolites
Measured: First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation
Secondary outcomes (1)
Plasma concentrations of hydroxyprogesterone caproate and metabolites
Measured: Up to 28 days following last dose given in week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumara Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Birch, PhD, Study director, Lumara Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899846
- Sponsor's protocol ID
- HPC-PK-005
- Status last verified
- Aug 2014
- First submitted
- 11 Jul 2013
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01899846
- Acronym / sponsor ID
- HPC-PK-005
- Conditions
- Pregnancy
- Keywords
- Makena, Pharmacokinetics, Prior preterm delivery, Hydroxyprogesterone Caproate, 17P
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lumara Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Hydroxyprogesterone caproate 250 mg/mlHydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation following first dose |
| Cohort 2 | Experimental | Drug: Hydroxyprogesterone caproate 250 mg/mlHydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 24 - 28 weeks gestation |
| Cohort 3 | Experimental | Drug: Hydroxyprogesterone caproate 250 mg/mlHydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 32 - 36 weeks gestation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Singleton gestation.
- Gestational age 16 weeks 0 days to 20 weeks 6 days.
- Previous singleton spontaneous preterm delivery
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxyprogesterone caproate 250 mg/mlAlso: Makena, 17P | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Plasma concentrations of hydroxyprogesterone caproate and metabolites
Time frame: First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation
1 secondary outcome
Plasma concentrations of hydroxyprogesterone caproate and metabolites
Time frame: Up to 28 days following last dose given in week 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Birch, PhD study director
Lumara Health, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydroxyprogesterone caproate 250 mg/ml in people with Pregnancy, run by Lumara Health, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of hydroxyprogesterone caproate and metabolites (time frame: First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2014.