DRUG
Bremelanotide
Sterile aqueous solution for injection, provided as an autoinjector pen
Status
Completed
Phase
Phase 1
Enrollment
228
Locations
1
Results
Not posted
Publications
0
Study 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.
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.
Interventions
DRUG
Sterile aqueous solution for injection, provided as an autoinjector pen
DRUG
8 mg tablet (over-encapsulation in a capsule)
DRUG
capsule
Timeline
First posted
Jun 4, 2019
Study start
Jun 17, 2019
Primary completion
Jul 19, 2019
Study completion
Jul 20, 2019
Results posted
Not reported
Registry updated
Apr 4, 2022
Outcomes
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.
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
Time to onset of nausea
Time frame · 2 Days
The time to onset of nausea
Duration of nausea
Time frame · 2 Days
The duration of nausea
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.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
ICON Early Phase Serrvices, LLC
San Antonio, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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