A Phase 1 interventional study of Midazolam and bitopertin in Healthy Volunteer, sponsored by Hoffmann-La Roche. Withdrawn. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-25.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
This will be a single-center, open-label, inpatient/outpatient, fixed-sequence study examining the effect of multiple doses of bitopertin on single doses of Midazolam in healthy volunteers.
A single oral dose on Midazolam (7.5 mg) will be administered on Day 1 after an overnight fast. Daily oral doses of bitopertin will be given under fed conditions from Days 2-13 and after fasting on Day 14. Oral doses of bitopertin and Midazolam (7.5 mg) will be co-administered on Day 15, after an overnight fast.
Pharmacokinetics will be assessed throughout. Total time on treatment is expected to be 15 days.
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: Midazolam · Drug: bitopertin
Single oral doses will be given on Days 1 and 15, after an overnight fast.
An oral dose will be given daily in the morning from Days 2-15. On Days 14 and 15, bitopertin will be given after an overnight fast; on Days 2-13, bitopertin will be given under fed conditions.
Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration
Time frame: Days 1 and 15
Change in 1'-hydroxymidazolam plasma AUC after bitopertin administration
Time frame: Days 1 and 15
Incidence of adverse events
Time frame: Approximately 76 days
No study locations are listed for this record.
This study is withdrawn, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hoffmann-La Roche