A Phase 1 interventional study of Placebo and RO5508887 in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in France. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 1 and Interventional
This randomized, double-blind, placebo-controlled, cross-over study will assess the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects will be randomized to receive single ascending doses of either RO5508887 or placebo. In Part 2, subjects will receive a single dose of RO5508887 on two occasions, with or without food. Anticipated time on study is up to 12 weeks.
Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: RO5508887
Drug: Placebo
Drug: RO5508887
Single ascending doses
Single ascending doses
Single doses
Safety/tolerability: Incidence of adverse events
Time frame: up to approximately 8 weeks
Pharmacokinetics: Plasma concentrations of RO5508887
Time frame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose
Pharmacodynamics: Urine levels of RO5508887
Time frame: predose to 72 hours post-dose
Pharmacodynamics: Plasma levels of markers of amyloid deposition (Abeta1-40/Abeta1-42)
Time frame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose
Effect of food on pharmacokinetics (plasma concentrations) of a single dose of RO5508887
Time frame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 36, 48, 60, 72 hours post-dose
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche