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A Study to Evaluate the Rate of Nausea in Healthy Premenopausal Female Subjects Treated With a Single Dose of Bremelanotide Alone or With Zofran

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ClinicalTrials.gov Identifier: NCT03973047
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

Brief Summary:
This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing. The study consists of a 21-day screening period for subject eligibility followed by a 1-day double-blind period in which all subjects receive a single open-label dose of 1.75 mg SC BMT after receiving a single blinded dose of Zofran (ondansetron) 8 mg or placebo. Approximately 228 subjects will be enrolled at up to two study sites in the United States. Safety and tolerability of BMT administration will be summarized and assessed.

Condition or disease Intervention/treatment Phase
Nausea Drug: Bremelanotide Drug: Zofran Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: BMT will be administered in an open-label manner. Administration of Zofran or placebo will be double-blinded using an over-encapsulation (OE) technique . The randomization assignments and code will not be provided to the Sponsor, sites, or subjects until the study database has been locked, except as unblinding is required for non-study personnel in the regulatory reporting of serious adverse events (SAEs) or for other safety-related reasons.
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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.
Drug: Bremelanotide
Sterile aqueous solution for injection, provided as an autoinjector pen
Other Name: BMT

Drug: Placebo
capsule

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.
Drug: Bremelanotide
Sterile aqueous solution for injection, provided as an autoinjector pen
Other Name: BMT

Drug: Zofran
8 mg tablet (over-encapsulation in a capsule)
Other Name: ondansetron




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. Time to onset of nausea [ Time Frame: 2 Days ]
    The time to onset of nausea

  3. Duration of nausea [ Time Frame: 2 Days ]
    The duration of nausea



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  1. Willing and able to provide written informed consent prior to participating in the study.
  2. 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]).
  3. Able to communicate clearly with the Principle Investigator (PI) and staff; able to read English, complete questionnaires, and understand study procedures.
  4. Able to complete all screening period evaluations, stay in the clinic testing facility for minimum of 4 hours following dose of BMT.
  5. 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:

  1. Postmenopausal female, designated by having amenorrhea for ≥12 months.
  2. 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.
  3. 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.
  4. 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).

  5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973047


Contacts
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Contact: Clinical Trial Interest 877-233-4781 AMAGCT@druginfo.com

Locations
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United States, Texas
ICON Early Phase Serrvices, LLC Recruiting
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.

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Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03973047     History of Changes
Other Study ID Numbers: AMAG-BMT-HSDD-102
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AMAG Pharmaceuticals, Inc.:
Nausea
Bremelanotide
BMT
Zofran
ondansetron
premenopausal
healthy women

Additional relevant MeSH terms:
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Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
alpha-MSH
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists