Safety and Tolerability of Oral Polyethylene Glycol (PEG 3350) Solution in Participants With Constipation (MK-8114-003)

Inclusion Criteria:

- ambulatory male or female with no history or current evidence of other conditions or
abnormalities that would affect study results or interfere with participation for
full duration of study

- meets diagnostic criteria for functional constipation. This includes loose stools
that are rarely present without the use of laxatives and 2 or more of the following:
straining during at least 25% of defecations; lumpy or hard stools in at least 25% of
defecations; sensation of incomplete evacuation for at least 25% of defecations;
sensation of anorectal obstruction/blockage for at least 25% of defecations; manual
maneuvers to facilitate at least 25% of defecations [e.g., digital evacuation,
support of the pelvic floor]; and fewer than 3 defecations per week. Criteria for
functional constipation must be fulfilled for last 3 months, with symptom onset at
least 6 months prior to diagnosis.

- continuous or recurrent symptoms for at least 3 months of: abdominal pain or
discomfort, relieved with defecation, or associated with a change in frequency or
consistency of stool, and an irregular pattern of defecation at least 25% of the time
with 3 or more of the following: altered stool frequency, altered stool form (hard or
loose/watery), altered stool passage (straining or urgency, feeling of incomplete
evacuation), passage of mucus, and bloating or abdominal distension

- agrees to not use laxatives other than study medication for the duration of the study
period

- agrees to not use disallowed concomitant medications for the duration of the study

- agrees to maintain a similar diet and level of activity from the period of the
Screening Visit through End of Study

- individuals of reproductive potential must agree to remain abstinent or use (or have
their partner use) 2 acceptable methods of birth control and until 2 weeks after the
last dose of study drug in the last treatment period. Acceptable methods of birth
control include: intrauterine device (IUD), diaphragm with spermicide, contraceptive
sponge, condom, or vasectomy.

Exclusion Criteria:

- abnormal baseline endoscopy and/or an oral exam

- baseline oral exam showing evidence of oral lesions, such as herpes labialis or
aphthous stomatitis, or known self-reported history or current periodontal gum
disease

- history of impaired swallowing or difficulties swallowing foods and liquids

- known, history of, or suspected gastrointenstinal disease, including bowel
perforation, obstruction, fecal impaction; irritable bowel syndrome (IBS), delayed
gastric emptying, gastroparesis, gastroesophageal reflux disease (GERD), gastritis or
peptic ulcer disease (PUD), dehydration, inflammatory bowel disease, bowel resection,
anal fistulas/fissures, colostomy, etc.

- severe or unexplained abdominal pain

- history of or current alcohol or drug abuse

- history of malignancy ≤5 years prior to signing the informed consent, except for
adequately treated basal cell and/or squamous cell skin cancer or in situ cervical
cancer

- history of psychiatric illness requiring medications or hospitalization within the
previous 12 months

- history of concurrent illness that required hospitalization within 4 weeks prior to
Day -1 of the study

- allergies or allergic reactions or intolerance to any of the products used in study

- any degree of renal impairment

- major surgery or clinically significant illness within 4 weeks prior to Day -1 of
Visit 1

- current or recent (within the past 30 days of signing informed consent)
participation in a study with an investigational compound or device

- refusal to agree not to donate eggs or sperm upon the first study drug administration
and thereafter through 90 days after the last study drug administration

- individual is an employee or family member of an employee of the sponsor or clinical
unit where study will be conducted