COMPLETED

A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027)

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of the study is to learn what happens to different forms of sotatercept medications in a healthy person's body over time. Researchers want to know if there is a difference in the healthy person's body when different forms of sotatercept medications are given.

Official Title

A Phase 1 Clinical Study in Healthy Females of Nonchildbearing Potential to Compare the Pharmacokinetics of Sotatercept (MK-7962) Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation

Quick Facts

Study Start:2025-05-16
Study Completion:2025-11-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06930664

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is in good health before randomization
  2. * Has a body weight between 75 and 100 kg, inclusive
  3. * Is assigned female sex at birth and is a participant of nonchildbearing potential (PONCBP) defined as one of the following:
  4. * Premenarchal
  5. * Premenopausal with documented hysterectomy and/or bilateral salpingectomy
  6. * Postmenopausal
  7. * Medical cause of permanent infertility (eg, Müllerian agenesis, androgen insensitivity)
  1. * Has a history of opportunistic infection (eg, invasive candidiasis or pneumocystis pneumonia)
  2. * Has had a serious local infection (eg, cellulitis, abscess) or systemic infection (eg, septicemia) within 3 months prior to screening

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Anaheim Clinical Trials ( Site 0007)
Anaheim, California, 92801
United States
Advanced Pharma CR, LLC ( Site 0005)
Miami, Florida, 33147
United States
QPS-MRA, LLC ( Site 0004)
South Miami, Florida, 33143
United States
Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0003)
Springfield, Missouri, 65802
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-16
Study Completion Date2025-11-25

Study Record Updates

Study Start Date2025-05-16
Study Completion Date2025-11-25

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy