A single-center, two part, non-randomized, open-label, one sequence, two period crossover study to investigate the drug-drug interaction effects of multiple doses of Rifampicin or Gemfibrozil on the PK and safety of a single oral dose of RO7017773 in healthy participants
- Conditions
- Autism Spectrum DisorderAutism
- Registration Number
- NL-OMON49446
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
1. Able and willing to provide written informed consent and to comply with the
study protocol according to International Conference on Harmonisation Good
Clinical Practice (ICH-GCP) and local regulations.
2. Participant must be 18 to 54 years of age inclusive, at the time of signing
the ICF.
3. Healthy, as judged by the Investigator. Healthy status will be defined as
the absence of evidence of any active or chronic disease following a detailed
medical and surgical history, a complete physical examination, vital signs,
12-lead ECG, hematology, blood chemistry, serology, and urinalysis.
4. Body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive at
Screening).
5. Male and female participants
•In Part 1: only male participants
•In Part 2: male and female participants
The contraception is intended to prevent exposure of an embryo to the study
treatment. Total abstinence, in accordance with the lifestyle of the
participant, is also acceptable.
The reliability of sexual abstinence for male and/or female 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 drug exposure.
a) Female participants (Part 2 only)
A female participant is eligible to participate if she is not pregnant, not
breastfeeding, and at least one of the following conditions applies:
• Women of non childbearing potential (WONCBP).
Women are considered to be of non-child bearing potential if postmenopausal at
least 12 months of amenorrhea and confirmed by follicle-stimulating hormone
(FSH), or surgically sterile (absence of ovaries and/or uterus; has undergone
bilateral tubal ligation).
• Women of childbearing potential (WOCBP)
Women of childbearing potential must agree to use one highly effective
contraceptive method that result in a failure rate of <1% per year from
screening until 90 days after the last dose of study drug (see Appendix 5 of de
protocol).
b) Male participants
During the treatment period and for at least 90 days after the last dose of
study drug, agreement to:
• Remain abstinent (refrain from heterosexual intercourse) or use a condom with
a female partner of childbearing potential (WOCBP), or pregnant female partner,
to avoid exposing the embryo.
• Refrain from donating sperm for at least 90 days after last dose.
1. Any condition or disease detected during the medical interview/physical
examination that would render the participant unsuitable for the study, place
the participant at undue risk or interfere with the ability of the participant
to complete the study, as determined by the Investigator.
2. History or evidence of any medical condition potentially altering the
absorption, metabolism, or elimination of drugs. This includes a surgical
history of the gastrointestinal tract affecting gastric motility or altering
the gastrointestinal tract.
3. History of any clinically significant gastrointestinal, renal, hepatic,
bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological,
hematological, or allergic disease, metabolic disorder, cancer, or cirrhosis.
4. Use of any psychoactive medication, or medications known to have effects on
the central nervous system (CNS) or blood flow taken within 4 weeks prior to
first dosing (or within 5 times the elimination half-life of the medication
prior to first dosing, whichever is longer).
5. History of convulsions (other than benign febrile convulsions of childhood)
including epilepsy, or personal history of significant cerebral trauma or CNS
infections (e.g. meningitis).
Further criteria apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part 1 and Part 2:<br /><br>RO7017773 plasma concentrations and RO7017773 PK parameters.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part 1 and 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 results during and after RO7017773 administration alone<br /><br>and in combination with rifampicin (Part 1) or gemfibrozil (Part 2).<br /><br><br /><br>Part 1:<br /><br>Concentrations and PK parameters for rifampicin.<br /><br><br /><br>Part 2:<br /><br>Concentrations and PK parameters for gemfibrozil and its metabolite<br /><br>(gemfibrozil 1-O-β-glucuronide).</p><br>