Current partner codePEPTIDESDE
NCT03973047·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

228

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Bremelanotide

Sterile aqueous solution for injection, provided as an autoinjector pen

DRUG

Zofran

8 mg tablet (over-encapsulation in a capsule)

DRUG

Placebo

capsule

Timeline

From registration to results.

  1. First posted

    Jun 4, 2019

  2. Study start

    Jun 17, 2019

  3. Primary completion

    Jul 19, 2019

  4. Study completion

    Jul 20, 2019

  5. Results posted

    Not reported

  6. Registry updated

    Apr 4, 2022

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
55 Years
Sex
FEMALE
Healthy volunteers
Yes

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

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

ICON Early Phase Serrvices, LLC

San Antonio, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Bremelanotide / PT-141.

Related PeptideStat pages

Put the record in context.

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