To Evaluate the Effect of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers

A Phase 1, Single-center, Fixed-sequence, Open Label Study to Evaluate the Effect of Oral
Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers

Inclusion Criteria:Have a body mass index (BMI) ≥18 and ≤30 kg/m2 and weigh at least 50 kg
and no more than 100 kg. Females of non-childbearing potential must be postmenopausal
defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal
treatments and follicle stimulating hormone (FSH) levels in the postmenopausal range or
documentation of irreversible surgical sterilization by hysterectomy,
bilateraloophorectomy or bilateral salpingectomy but not tubal ligation

Females of childbearing potential must have a negative pregnancy test at screening, Day
-1, and Day 14 and must not be lactating and use effective contraceptive methods to avoid
pregnancy during the treatment period

Male healthy volunteers with a partner of childbearing potential must agree to avoid
fathering a child, and refrain from donating sperm, from the first day of dosing until at
least 3 months after last dose of the investigational product, and therefore be either
sterile or agree to use approved methods of contraception

Exclusion Criteria:

- History of any clinically significant disease or disorder which, in the opinion of
the principal investigator, may either put the healthy volunteer at risk because of
participation in the study, or influence the results or the healthy volunteer's
ability to participate in the study. History or presence of GI, hepatic or renal
disease including GI surgery other than appendectomy or any other condition known to
interfere with the absorption, distribution, metabolism or excretion of drugs. Loose
stools (BSFS of 6 or 7) ≥2 days in the past 7 days before investigational product
administration. Use of medications that are known to affect stool consistency and/or
GI motility, including fiber supplements, anti-diarrheals, prokinetic drugs, enemas,
probiotic medications or supplements, or salt or electrolyte supplements containing
sodium, potassium, chloride, or bicarbonate formulations during the past 7 days
before the investigational product administration. Use of any prescribed or
non-prescribed medication including antacids, analgesics other than
paracetamol/acetaminophen, herbal remedies, vitamins and minerals during the 2 weeks
prior to the first administration of investigational product or longer if the
medication has a long half-life. Use of drugs or substances with enzyme-inducing
properties within 4 weeks prior to the first administration of investigational
product.