CClinicalTrials.gg
WithdrawnNCT02019290Updated Oct 25, 2017

A Study Exmining the Effect of Multiple Doses of Bitopertin on the Single Dose Pharmacokinetics of Midazolam in Healthy Volunteers.

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 Withdrawn.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

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male and female volunteers, 18 to 65 years of age, inclusive.
  • A BMI between 18 to 30 kg/m2, inclusive.
  • Healthy as determined by the Investigator on the basis of medical/surgical history, physical examination, clinical laboratory test results, vital signs and 12-lead electrocardiogram (ECG)
  • Female participants must use effective contraception as defined by the protocol and cannot be pregnant or breastfeeding
  • Non-smoker or smoker of fewer than 10 cigarettes per day
  • Must be able to refrain from smoking during the in-patient stay

Exclusion criteria

Exclusion Criteria:

  • Personal or family history of congenital long QT syndrome or family history of sudden death
  • Any major illness within the 4 weeks prior to dosing or any acute disease state within 7 days prior to study start
  • History of alcoholism, drug abuse or addiction within the last year prior to study start, or suspicion of drug abuse/addiction or alcohol use prior to study start
  • Current alcohol consumption averaging more than 24 g of alcohol per day
  • Any significant allergic reactions against any drug, or multiple allergies in the judgment of the Investigator
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    bitopertin-Midazolam

    Drug: Midazolam · Drug: bitopertin

Interventions

  • DrugMidazolam

    Single oral doses will be given on Days 1 and 15, after an overnight fast.

  • Drugbitopertin

    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.

06

What researchers measure

Primary outcomes

  1. Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration

    Time frame: Days 1 and 15

Secondary outcomes

  1. Change in 1'-hydroxymidazolam plasma AUC after bitopertin administration

    Time frame: Days 1 and 15

  2. Incidence of adverse events

    Time frame: Approximately 76 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02019290
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Dec 24, 2013
Start date
Feb 10, 2014 (estimated)
Primary completion
Mar 31, 2014 (estimated)
Completion
Mar 31, 2014 (estimated)
Last update
Oct 25, 2017

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Start the discussion