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

NCT03973047 | Completed Phase 1 FDA Drug

• 1 other identifier: AMAG-BMT-HSDD-102
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea

Keywords

Nausea; Bremelanotide; BMT; Zofran; ondansetron; premenopausal; healthy women

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent nausea following BMT with or without concomitant use of Zofran.

  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 Outcomes (3)

• Severity of nausea using a Visual Analog Scale

  2 Days

• Time to onset of nausea

  2 Days

• Duration of nausea

  2 Days

Study Arms (2)

Group 1: BMT plus placebo

PLACEBO COMPARATOR

1 dose of BMT 1.75 mg via autoinjector plus placebo (dosed 30±5 minutes prior to BMT dosing) on Day 1.

Drug: Bremelanotide; Drug: Placebo

Group 2: BMT plus Zofran

ACTIVE COMPARATOR

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; Drug: Zofran

Interventions

Bremelanotide DRUG

Sterile aqueous solution for injection, provided as an autoinjector pen

Also known as: BMT

Group 1: BMT plus placebo; Group 2: BMT plus Zofran

Zofran DRUG

8 mg tablet (over-encapsulation in a capsule)

Also known as: ondansetron

Group 2: BMT plus Zofran

Placebo DRUG

capsule

Group 1: BMT plus placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AMAG Pharmaceuticals, Inc.: lead

Study Sites (1)

ICON Early Phase Serrvices, LLC

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Nausea

Interventions

bremelanotide; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 4, 2019
• Study Start: June 17, 2019
• Primary Completion: July 19, 2019
• Study Completion: July 20, 2019
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)