- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03973047
Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran
A Phase 1, Randomized Study to Evaluate the Rate of Nausea in Healthy Premenopausal Female Subjects Treated With a Single Dose of Bremelanotide Alone or With Zofran
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78209
- ICON Early Phase Serrvices, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- Willing and able to provide written informed consent prior to participating in the study.
- Female subjects ≥18 to 55 years of age (inclusive) and premenopausal as defined by the modified STRAW criteria (specifically, Stage -5 [menses variable to regular] through Stage 1 [≥2 skipped cycles and an interval of amenorrhea ≥60 days]).
- Able to communicate clearly with the Principle Investigator (PI) and staff; able to read English, complete questionnaires, and understand study procedures.
- Able to complete all screening period evaluations, stay in the clinic testing facility for minimum of 4 hours following dose of BMT.
- In good general health, free from clinically significant medical or psychiatric illness or disease (as determined by medical/surgical history, physical examination, weight, 12-lead ECG, and clinical laboratory tests).
Key Exclusion Criteria:
- Postmenopausal female, designated by having amenorrhea for ≥12 months.
- Has current or recent (within 6 months) history of gastrointestinal disease, or any surgical or medical condition such as Crohn's disease or liver disease, that could potentially alter the absorption, metabolism, or excretion of the study drug.
- Has any clinically significant medical condition, physical exam finding, or ECG abnormality, or clinically significant abnormal value for hematology, serology, clinical chemistry, or urinalysis at Screening, or at admission to the study center, as assessed by the PI.
Has any of the following:
- History or current diagnosis of uncontrolled hypertension defined as: Two (2) sequential assessments (at least 5 minutes apart and no more than 15 minutes apart) at levels >140 mmHg SBP or 90 mmHg DBP and/or treatment for hypertension that has been changed at least once in the 4 weeks before Screening.
- Renal dysfunction (creatinine clearance < 80 mL/min using Cockcroft Gault calculation).
- History or presence of malignancy within the past 5 years, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma), which is allowed.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Group 1: BMT plus placebo
1 dose of BMT 1.75 mg via autoinjector plus placebo (dosed 30±5 minutes prior to BMT dosing) on Day 1.
|
capsule
Sterile aqueous solution for injection, provided as an autoinjector pen
Other Names:
|
Active Comparator: Group 2: BMT plus Zofran
1 dose of BMT 1.75 mg via autoinjector plus Zofran 8 mg (dosed 30±5 minutes prior to BMT dosing) on Day 1.
|
Sterile aqueous solution for injection, provided as an autoinjector pen
Other Names:
8 mg tablet (over-encapsulation in a capsule)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment-emergent nausea following BMT with or without concomitant use of Zofran.
Time Frame: 2 Days
|
Incidence of treatment-emergent nausea following a single dose of BMT 1.75 mg SC with or without concomitant use of Zofran.
|
2 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of nausea using a Visual Analog Scale
Time Frame: 2 Days
|
"Severity of Nausea Visual Analog Scale", where the range is 0 to 100 and a lower value represents a better outcome
|
2 Days
|
Time to onset of nausea
Time Frame: 2 Days
|
The time to onset of nausea
|
2 Days
|
Duration of nausea
Time Frame: 2 Days
|
The duration of nausea
|
2 Days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Antipruritics
- Ondansetron
Other Study ID Numbers
- AMAG-BMT-HSDD-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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