None listed
Conditions
Interventions
THE STUDY CONSISTS OF TWO PARTS, PART 1 AND PART 2.
PART 1 IS A DOSE RANGING STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND EFFICACY OF MK-4618 AND ASSESS PROOF OF CONCEPT FOR THE CONCOMITANT ADMINI
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: VISIT 1 INCLUSION CRITERIA (PART 1 AND PART 2) 1. PATIENT UNDERSTANDS THE STUDY PROCEDURES, ALTERNATIVE TREATMENTS AVAILABLE, AND RISKS INVOLVED WITH THE STUDY, AND VOLUNTARILY AGRESS TO PARTICIPE BY GIVING WRITTEN INFORMED CONSENT. 2. PATIENT IS MALE OR FEMALE OF NON-CHILDBEARING POTENTIAL BETWEEN 40 AND 75 YEARS OF AGE INCLUSIVE ON DAY OF THE SIGNING INFORMED CONSENT. NOTE: A FEMALE PATIENT WHO IS OF NON-CHILDBEARING POTENTIAL IS DEFINED AS ONE WHO HAS EITHER 1) REACHED NATURAL MENOPAUSE [12 MONTHS OF SPONTANEOUS AMENORRHEA OR 6 MONTHS OF SPONTANEOUS AMENORRHEA AND FSH LEVELS IN POSTMENOPAUSAL RANGE AS DETERMINED BY THE CENTRAL LABORATORY], 2) 6 WEEKS POST SURGICAL BILATERAL OOPHORECTOMY WITH OR WITHOUT HYSTERECTOMY, 3) BILATERAL TUBAL LIGATION, OR 4) HYSTERECTOMY. NOTE: A MALE PATIENT WHO IS OF REPRODUCTIVE POTENTIAL AGREES TO REMAIN ABSTINENT OR USE (OR HAVE HIS PARTNER USE) 2 ACCEPTABLE METHODS OF BIRTH CONTROL WITHIN THE PROJECTED DURATION OF THE STUDY. ACCEPTABLE METHODS OF BIRTH CONTROL ARE: INTRAUTERINE DEVICE (IUD), DIAPHRAGM WITH SPERMICIDE, CONTRACEPTIVE SPONGE, CONDOM, VASECTOMY. NOTE: UP TO 10% OF PATIENTS CAN BE MALE.
Exclusion criteria
Exclusion criteria: VISIT 1 EXCLUSION CRITERIA (PART 1 AND PART 2) GENERAL MEDICAL 1. PATIENT HAS A HISTORY OR CURRENT EVIDENCE OF ANY CONDITION, THERAPY, LAB ABNORMALITY OR OTHER CIRCUMSTANCE THAT MIGHT CONFOUND THE RESULTS OF THE STUDY, OR INTERFERE WITH THE PATIENT´S PARTICIPATION FOR THE FULL DURATION OF THE STUDY, SUCH THAT IT IS NOT IN THE BEST INTEREST OF THE PATIENT TO PARTICIPATE. 2. PATIENT HAS EVIDENCE OF DIABETES INSIPIDUS, UNCONTROLLED HYPERGLYCEMIA (FASTING BLOOD GLUCOSE > 150 MG/DL OR 8.33 MMOL/L AND/OR NON FASTING BLOOD GLUCOSE > 180 MG/DL OR 10.0 MMOL/L), OR UNCONTROLLED HYPERCALCEMIA (BLOOD TOTAL CALCIUM > 11 MG/DL OR 2.75 MMOL/L). 3. PATIENT IS BREASTFEEDING. 4. PATIENT HAS A HISTORY OF MALIGNANCY ≤ 5 YEARS PRIOR TO SIGNING INFORMED CONSENT, EXCEPT FOR ADEQUATELY TREATD BASAL CELL OR SQUAMOUS CELL SKIN CANCER OR IN SITU CERVICAL CANCER. MELANOMA, LEUKEMIA, LYMPHOMA AND MYELOPROLIFERATIVE DISORDERS OF ANY DURATION ARE EXCLUDED. 5. PATIENT HAS A SYSTOLIC BLOOD PRESSURE > 160 mmHG OR DIASTOLIC BLOOD PRESSURE > 90 mmHG OR RESTING HEART RATE (BY PULSE) > 100 BEATS PER MINUTE AT VISIT 1. 6. PATIENT HAS EVIDENCE FROM CURRENT HISTORY OF SYMPTOMATIC ORTHOSTATIC HYPOTENSION.
Outcome results
None listed