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

Primary Purpose

Nausea

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Bremelanotide

Zofran

Placebo

About this trial

This is an interventional treatment trial for Nausea focused on measuring Nausea, Bremelanotide, BMT, Zofran, ondansetron, premenopausal, healthy women

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Key Inclusion Criteria:

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).

Key Exclusion Criteria:

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.

Sites / Locations

ICON Early Phase Serrvices, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group 1: BMT plus placebo

Group 2: BMT plus Zofran

Arm Description

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

1 dose of BMT 1.75 mg via autoinjector plus Zofran 8 mg (dosed 30±5 minutes prior to BMT dosing) on Day 1.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Severity of nausea using a Visual Analog Scale

"Severity of Nausea Visual Analog Scale", where the range is 0 to 100 and a lower value represents a better outcome

Time to onset of nausea

The time to onset of nausea

Duration of nausea

The duration of nausea

Full Information

NCT ID

NCT03973047

First Posted

May 31, 2019

Last Updated

March 31, 2022

Sponsor

AMAG Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03973047

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

June 17, 2019 (Actual)

Primary Completion Date

July 19, 2019 (Actual)

Study Completion Date

July 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AMAG Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

228 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: BMT plus placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Group 2: BMT plus Zofran

Arm Type

Active Comparator

Arm Description

1 dose of BMT 1.75 mg via autoinjector plus Zofran 8 mg (dosed 30±5 minutes prior to BMT dosing) on Day 1.

Intervention Type

Drug

Intervention Name(s)

Bremelanotide

Other Intervention Name(s)

BMT

Intervention Description

Sterile aqueous solution for injection, provided as an autoinjector pen

Intervention Type

Drug

Intervention Name(s)

Zofran

Other Intervention Name(s)

ondansetron

Intervention Description

8 mg tablet (over-encapsulation in a capsule)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

capsule

Primary Outcome Measure Information:

Title

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

Description

Incidence of treatment-emergent nausea following a single dose of BMT 1.75 mg SC with or without concomitant use of Zofran.

Time Frame

2 Days

Secondary Outcome Measure Information:

Title

Severity of nausea using a Visual Analog Scale

Description

"Severity of Nausea Visual Analog Scale", where the range is 0 to 100 and a lower value represents a better outcome

Time Frame

2 Days

Title

Time to onset of nausea

Description

The time to onset of nausea

Time Frame

2 Days

Title

Duration of nausea

Description

The duration of nausea

Time Frame

2 Days

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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). Key Exclusion Criteria: 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.

Facility Information:

Facility Name

ICON Early Phase Serrvices, LLC

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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