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

NCT ID: NCT03973047

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-17
• Study Completion Date: 2019-07-20

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.

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.

Conditions

Nausea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Bremelanotide

Intervention Type: DRUG

Sterile aqueous solution for injection, provided as an autoinjector pen

Placebo

Intervention Type: DRUG

capsule

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.

Group Type: ACTIVE_COMPARATOR

Bremelanotide

Intervention Type: DRUG

Sterile aqueous solution for injection, provided as an autoinjector pen

Zofran

Intervention Type: DRUG

8 mg tablet (over-encapsulation in a capsule)

Interventions

Bremelanotide

Sterile aqueous solution for injection, provided as an autoinjector pen

Intervention Type: DRUG

Zofran

8 mg tablet (over-encapsulation in a capsule)

Intervention Type: DRUG

Placebo

capsule

Intervention Type: DRUG

Other Intervention Names

BMT; ondansetron

Eligibility Criteria

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).

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

AMAG Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICON Early Phase Serrvices, LLC

San Antonio, Texas, United States

Countries

United States

Other Identifiers

AMAG-BMT-HSDD-102

Identifier Type: -

Identifier Source: org_study_id