Healthy VolunteerPhase 1NCT02019290

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

A Phase 1 study testing Midazolam and bitopertin in people with Healthy Volunteer, run by Hoffmann-La Roche.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: Midazolam and bitopertin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 10 Feb 2014to 31 Mar 2014
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE BITOPERTIN ON SINGLE DOSE PHARMACOKINETICS OF MIDAZOLAM IN HEALTHY VOLUNTEERS

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.

Conditions: Healthy Volunteer
Being tested: Midazolam, bitopertin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02019290
Study group	Role	What they receive
bitopertin-Midazolam	Experimental	Not described Receives: Drug: Midazolam; Drug: bitopertin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration
Measured: Days 1 and 15

Secondary outcomes (2)

Change in 1'-hydroxymidazolam plasma AUC after bitopertin administration
Measured: Days 1 and 15
Incidence of adverse events
Measured: Approximately 76 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 201431 Mar 2014

First posted24 Dec 2013 (estimated)
Study start10 Feb 2014 (estimated)
Primary completion31 Mar 2014 (estimated)
Study completion31 Mar 2014 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteerStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02019290
Sponsor's protocol ID: BP29245
Status last verified: Oct 2017
First submitted: 18 Dec 2013
Last updated: 25 Oct 2017
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
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Active, not recruitingPhase 2
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A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
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All Healthy Volunteer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE BITOPERTIN ON SINGLE DOSE PHARMACOKINETICS OF MIDAZOLAM IN HEALTHY VOLUNTEERS
ClinicalTrials.gov ID: NCT02019290
Acronym / sponsor ID: BP29245
Conditions: Healthy Volunteer
Phase: Phase 1
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 10 Feb 2014 (estimated)
Primary completion: 31 Mar 2014 (estimated)
Study completion: 31 Mar 2014 (estimated)
First posted: 24 Dec 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Pharmacokinetics will be assessed throughout. Total time on treatment is expected to be 15 days.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
bitopertin-Midazolam	Experimental	Drug: Midazolam, Drug: bitopertin

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MidazolamSingle oral doses will be given on Days 1 and 15, after an overnight fast.	Drug	bitopertin-Midazolam
bitopertinAn 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.	Drug	bitopertin-Midazolam

Primary outcome

Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration
Time frame: Days 1 and 15

2 secondary outcomes

Change in 1'-hydroxymidazolam plasma AUC after bitopertin administration
Time frame: Days 1 and 15
Incidence of adverse events
Time frame: Approximately 76 days

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.

Related trials for Healthy Volunteer

Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingPhase 4
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
Healthy Participants

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Midazolam and bitopertin in people with Healthy Volunteer, run by Hoffmann-La Roche.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration (time frame: Days 1 and 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02019290.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.