Asthma
Conditions
Interventions
SAD:
The volunteer will be given GDC-6599 or placebo as tablets orally with 240 mL
of water or as a suspension (a drink). After administration of the suspension,
the vial will be rinsed twice with
Sponsors
Genentech, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Signed Informed Consent Form - Age 18*75 years at time of signing Informed Consent Form - Ability to comply with the study protocol, in the investigator*s judgment - Body mass index of 18*30 kg/m2 at screening - Veins suitable for venipuncture and/or cannula insertion to accommodate blood sample collection at multiple timepoints during the study
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days after the final dose of study drug during the SAD/FE stage and for 28 days after the final dose of study drug during the MAD stage, unless a longer period is required by local regulations or ethics committee Women must have a negative serum pregnancy test result within 1 day prior to initiation of study drug. - History of easy bruising or bleeding (i.e., bruising or bleeding out of proportion to the degree of trauma) - Use of anticoagulant or anti-platelet therapies - History of significant hepatic impairment, defined as Child-Pugh Class B or C, corresponding to a Child-Turcotte-Pugh Score >= 7 - History of abuse, in the investigator's judgment, of drugs including, but not limited to the following: amphetamines, barbiturates, benzodiazepines, cocaine, marijuana/cannabis, methadone, methamphetamine, ecstasy, morphine/opiates, phencyclidine, and tricyclic antidepressants within 12 months prior to screening and clinic admission A positive drug screen test for any of the drugs listed above at screening is exclusionary.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence and severity of adverse events, with severity determined according to the DAIDS toxicity grading scale - Change from baseline in targeted vital signs - Change from baseline in targeted clinical laboratory test results - Change from baseline in ECG parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| - Plasma concentration of GDC-6599 at specified timepoints - Plasma concentration of GDC-6599 at specified timepoints in subjects receiving GDC-6599 under fasting and fed conditions | — |
Countries
Netherlands
Outcome results
None listed