A single-center, two-part, randomized, open-label, parallel-group, four-sequence, four-treatment, four-period crossover study to investigate the bioequivalence and the effect of food on the pharmacokinetics and safety of single oral doses of two different formulations of RO6868847 in healthy participants
- Conditions
- non-proliferate diabetic retinopathy (NPDR)10012653
- Registration Number
- NL-OMON51381
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
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 <1% per year during the treatment period and for at least 90
days after the last dose of study treatment. Examples of contraceptive methods
with a failure rate of <1% per year include bilateral tubal occlusion,
intercourse with a sterilized male, established proper use of hormonal
contraceptives that inhibit ovulation, hormone-releasing intrauterine devices,
and copper intrauterine devices.
- Has a negative pregnancy test at screening and Day -1.
b) Male:
During the treatment period and for at least 90 days after the last dose of
study treatment, agree 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 <1% per year as described above, with a partner who is a WOCBP.
• With pregnant female partner, remain abstinent (refrain from heterosexual
intercourse) or use contraceptive measures such as a condom to avoid exposing
the embryo.
• Refrain from donating sperm.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part 1 (Bioequivalence)<br /><br>RO6868847 plasma concentrations and derived pharmacokinetic (PK) parameters.<br /><br><br /><br><br /><br>Part 2 (Food Effect)<br /><br>RO6868847 plasma concentrations and derived pharmacokinetic (PK) parameters.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part 1 and Part 2<br /><br>Incidence and severity of adverse events (AEs).<br /><br>Changes in vital signs, physical findings, electrocardiogram (ECG) parameters,<br /><br>and clinical laboratory test results.</p><br>