non-proliferate diabetic retinopathy (NPDR)
Conditions
Interventions
All doses are administered on Day 1 as a single dose as follows:
Part 1 (fasted condition)
A: 30 mg RO6868847 Type 1/2
B: 30 mg RO6868847 Type 3
C: 200 mg RO6868847 Type 1/2
D: 200 mg RO6868847 T
Sponsors
Hoffmann-La Roche
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Willing to participate and able to give written informed consent and to comply with the study restrictions according to International Council for Harmonisation (ICH) and local regulations. 2. Male or female, between 18 to 64 years of age, inclusive, at screening. 3. Healthy participants. Health status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology, coagulation, and urinalysis. 4. Participants must weigh at least 50.0 kg and must have a body mass index (BMI) within the range of 18.0 to 32.0 kg/m2, inclusive. 5. Male and female: The contraception and abstinence requirements are intended to prevent exposure of an embryo to the study treatment. The reliability of sexual abstinence for enrollment eligibility needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of preventing fetal/embryonic drug exposure. a) Female: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: • Woman of non-childbearing potential (WONCBP). • Woman of childbearing potential (WOCBP), who: - Agrees to remain abstinent (refrain from heterosexual intercourse) or use a condom plus an additional highly effective contraceptive method that results in a failure rate of
Exclusion criteria
Exclusion criteria: 1. History of any clinically significant gastrointestinal, renal, hepatic, broncho pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, or cirrhosis. 2. 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 participant in this study including, but not limited to, any major illness within 4 weeks before the screening examination or any febrile illness within 1 week prior to screening and up to first study treatment administration. 3. History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs. Surgical history of the gastrointestinal tract affecting gastric motility or altering the gastrointestinal tract (with the exception of uncomplicated appendectomy and hernia repair). 4. History or presence of clinically significant ECG abnormalities based on the average of triplicate ECG recordings (e.g., PQ/PR interval >210 ms, QTcF >450 ms for males and QTcF >470 ms for females) or cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death). 5. History of malignancy in the past 5 years. Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 (Bioequivalence) RO6868847 plasma concentrations and derived pharmacokinetic (PK) parameters. Part 2 (Food Effect) RO6868847 plasma concentrations and derived pharmacokinetic (PK) parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 and Part 2 Incidence and severity of adverse events (AEs). Changes in vital signs, physical findings, electrocardiogram (ECG) parameters, and clinical laboratory test results. | — |
Countries
Netherlands
Outcome results
None listed