A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7079901 and the Combination of RO7079901 With Meropenem in Adult Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 5/20/2017 |
| Start Date: | October 31, 2016 |
| End Date: | March 24, 2017 |
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of RO7079901 Administered Intravenously Both Alone and in Combination With Meropenem in Adult Healthy Volunteers
This is a randomized, double-blind, placebo-controlled, multiple-ascending dose (MAD) study
that will evaluate the safety, tolerability and pharmacokinetics (PK) of RO7079901 and the
combination of RO7079901 with meropenem in healthy volunteers. The study will consist of
three parts (Part I, II, and III). At each dose level/cohort, a total of 8 healthy
volunteers will be randomized to receive active study drug or placebo in a 3:1 ratio.
that will evaluate the safety, tolerability and pharmacokinetics (PK) of RO7079901 and the
combination of RO7079901 with meropenem in healthy volunteers. The study will consist of
three parts (Part I, II, and III). At each dose level/cohort, a total of 8 healthy
volunteers will be randomized to receive active study drug or placebo in a 3:1 ratio.
Inclusion Criteria:
- Healthy male or healthy female of non-childbearing-potential
- A Body Mass Index (BMI) between 18.0 and 30.0 kilograms per square meter (kg/m^2)
(inclusive) and a body weight of at least 45 kilograms (kg) at screening
- Negative urine drug and alcohol screen (barbiturates, benzodiazepines, methadone,
amphetamines, methamphetamines, opiates, cocaine, cannabinoids, cotinine, and
alcohol)
- Non-smokers, or former smokers, who have not smoked for at least 60 days prior to
screening
Exclusion Criteria:
- Known history of any significant hypersensitivity or severe allergic reaction to any
beta-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems, or
monobactams)
- History of any severe antibiotic-associated superinfections like Clostridium
difficile colitis and/or frequent fungal vaginal infections
- Concurrent or history of clinically significant cardiovascular, hepatic, renal,
endocrine, gastrointestinal, respiratory, psychiatric, neurologic, and/or
hematological disorders
- A history or presence of malignancy (with the exception of successfully treated basal
cell carcinoma); seizures, brain lesions or other significant neurological diseases
- Donation of blood (or loss of blood) greater than 500 milliliters (mL) within three
months before screening
- History of Gilbert syndrome
- Any clinically significant concomitant disease or condition that could interfere
with, or treatment of which might interfere with, the conduct of the study, or that
would, in the opinion of the investigator, pose an unacceptable risk to the healthy
volunteer in this study
- Positive test at screening of any of the following: Hepatitis A Virus Immunoglobulin
M Antibody (HAV IgM Ab), Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus
Ribonucleic Acid or Hepatitis C Virus Antibody (HCV RNA or HCVAb), or Human
Immunodeficiency Virus Antibody (HIV Ab)
We found this trial at
2
sites
617 Oakley Street
Evansville, Indiana 47710
Evansville, Indiana 47710
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