Pt B C4 Checking in 12Aug

Study Details

This is a research study for an investigational drug being developed for the potential treatment of obesity.

Fortrea Dallas, TX is recruiting for:

Healthy Men and Women of Non-Childbearing Potential, age 18-65

Women Eligibility Criteria

Must be of non-childbearing potential due to postmenopausal status or permanently sterile at least 6 weeks prior including:

• hysterectomy
• bilateral salpingo-oophorectomy
• bilateral salpingectomy
• bilateral oophorectomy

• aged at least 40 years and up to 55 years with an intact uterus, not on hormone therapy, who has had cessation of menses for at least 12 consecutive months without an alternative medical cause, AND with a follicle stimulating hormone ≥40 mIU/mL. **Note: females in this category cannot be using hormone replacement therapy.

• 55 years or older not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea. 

• aged at least 55 years with a diagnosis of menopause prior to starting hormone replacement therapy.

Body Mass Index

Participants must have a BMI of:
20-29.9

Smoking criteria

Must not smoke more than 10 cigarettes per day

Screening procedures

Screening procedures for this study may include:
Vitals
Physical examination
Electrocardiogram (ECG)
Collection of blood samples
Mental health questionnaire (C-SSRS)
Drug and Alcohol testing

Additional Details

Pt B C4:

Check-in: Aug 12, 19, 26, Sep 2, 9, 17

Check-out: Aug 17, 20, 27, Sep 3, 10, 18

OPV: Sep 19, 20, 21, 24, Oct 8, 22, Nov 5, 19, Dec 10

Phone calls: Aug 21, 22, 28, 29, Sep 4, 5, 11, 12