This study was a randomized, double‐blind, placebo‐controlled, single ascending dose study following oral administration of RO6870868 to healthy volunteers. For dose escalation, 10 subjects were sequentially enrolled into cohorts, receiving 200, 400, 800, 1200, 1600, or 2000 mg RO6870868 or placebo (8 active/2 placebo). Rationale for starting dose is described in Supplementary Information S2. Subjects were housed in a clinical research unit for 4 nights from day −2 to day 3. On day 1, subjects were administered a single oral RO6870868 dose or placebo in the fasted state. Escalation to the next dose group was based upon review of safety, tolerability, and PK data with mutual agreement between the sponsor and the investigator. In all cohorts, follow‐up was conducted with a visit 7 days after the single dose, and a follow‐up call on postdose day 28.

The study protocol and its amendments were reviewed and approved by the responsible ethics committee (Stichting Beoordeling Ethiek Biomedisch Onderzoek [Stichting BEBO]) and by the Netherland’s Competent Authority (The Centrale Commissie Mensgebonden Onderzoek [CCMO]): Sponsor‐code NP28628, CRO‐code RHE390EC‐123901, CCMO‐code NL45513.056.13. Written informed consent was obtained from each subject participating in the study. The study was conducted at the phase I unit of PRA Health Sciences (Groningen, The Netherlands) in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines.

Note: The content above has been extracted from a research article, so it may not display correctly.

Please log in to submit your questions online.
Your question will be posted on the Bio-101 website. We will send your questions to the authors of this protocol and Bio-protocol community members who are experienced with this method. you will be informed using the email address associated with your Bio-protocol account.

We use cookies on this site to enhance your user experience. By using our website, you are agreeing to allow the storage of cookies on your computer.