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

Last updated: March 31, 2022
Sponsor: AMAG Pharmaceuticals, Inc.
Overall Status: Completed

Phase

1

Condition

Colic

Stomach Discomfort

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT03973047
AMAG-BMT-HSDD-102
  • Ages 18-55
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Willing and able to provide written informed consent prior to participating in thestudy.
  2. Female subjects ≥18 to 55 years of age (inclusive) and premenopausal as defined by themodified STRAW criteria (specifically, Stage -5 [menses variable to regular] throughStage 1 [≥2 skipped cycles and an interval of amenorrhea ≥60 days]).
  3. Able to communicate clearly with the Principle Investigator (PI) and staff; able toread English, complete questionnaires, and understand study procedures.
  4. Able to complete all screening period evaluations, stay in the clinic testing facilityfor minimum of 4 hours following dose of BMT.
  5. In good general health, free from clinically significant medical or psychiatricillness or disease (as determined by medical/surgical history, physical examination,weight, 12-lead ECG, and clinical laboratory tests).

Exclusion

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 anysurgical or medical condition such as Crohn's disease or liver disease, that couldpotentially alter the absorption, metabolism, or excretion of the study drug.
  3. Has any clinically significant medical condition, physical exam finding, or ECGabnormality, 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) atlevels >140 mmHg SBP or 90 mmHg DBP and/or treatment for hypertension that has beenchanged at least once in the 4 weeks before Screening.
  • Renal dysfunction (creatinine clearance < 80 mL/min using Cockcroft Gaultcalculation).
  1. History or presence of malignancy within the past 5 years, with the exception ofadequately treated localized skin cancer (basal cell or squamous cell carcinoma),which is allowed.

Study Design

Total Participants: 228
Study Start date:
June 17, 2019
Estimated Completion Date:
July 20, 2019

Study Description

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.

Connect with a study center

  • ICON Early Phase Serrvices, LLC

    San Antonio, Texas 78209
    United States

    Site Not Available

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