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

Nausea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03973047
• Other study ID #: AMAG-BMT-HSDD-102
• Status: Completed
• Phase: Phase 1
• Start date: June 17, 2019
• Est. completion date: July 20, 2019

Study information

• Verified date: March 2022
• Source: AMAG Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: July 20, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea

Intervention

Drug:
• Bremelanotide
Sterile aqueous solution for injection, provided as an autoinjector pen
• Zofran
8 mg tablet (over-encapsulation in a capsule)
• Placebo
capsule

Locations

Country	Name	City	State
United States	ICON Early Phase Serrvices, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AMAG Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	2 Days
Secondary	Time to onset of nausea	The time to onset of nausea	2 Days
Secondary	Duration of nausea	The duration of nausea	2 Days