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

March 31, 2022 updated by: AMAG Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

228

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • San Antonio, Texas, United States, 78209
        • ICON Early Phase Serrvices, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • BMT
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:
  • BMT
8 mg tablet (over-encapsulation in a capsule)
Other Names:
  • ondansetron

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2019

Primary Completion (Actual)

July 19, 2019

Study Completion (Actual)

July 20, 2019

Study Registration Dates

First Submitted

May 31, 2019

First Submitted That Met QC Criteria

May 31, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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