Autism Spectrum Disorder Autism
Conditions
Interventions
Part 1:
RO7017773 will be given as oral tablets with 240 milliliters (mL) of water.
Rifampicin will be given as oral capsules with 240 mL of water.
The planned treatments are as follows:
Day Treat
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 and Part 2: RO7017773 plasma concentrations and RO7017773 PK parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 and 2: •Incidence and severity of adverse events (AEs). •Changes in vital signs, physical findings, electrocardiogram (ECG) parameters, and clinical laboratory results during and after RO7017773 administration alone and in combination with rifampicin (Part 1) or gemfibrozil (Part 2). Part 1: Concentrations and PK parameters for rifampicin. Part 2: Concentrations and PK parameters for gemfibrozil and its metabolite (gemfibrozil 1-O-β-glucuronide). | — |
Countries
Netherlands
Outcome results
None listed