HealthyPhase 1NCT01806415
Pharmacokinetics and Side Effects of the mGlu5 Antagonist Fenobam in Adult Healthy Volunteers
A Phase 1 study testing Fenobam in people with Healthy, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is a randomized, blinded, parallel group, placebo-controlled trial on 32 evaluable healthy male and non-pregnant female, 18-50 year old volunteers. The investigators goal is to observe the pharmacokinetics of fenobam after oral administration of 50, 100 or 150 mg in groups of healthy individuals and to compare… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fenobam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Sep 2015
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 yr old
- Good general health with no remarkable medical conditions (e.g liver, kidney, heart, or lung failure), BMI<33 and no known drug allergies.
- Willing to comply with study guidelines as outlined in protocol
- Willing to provide informed consent.
Who cannot join
- Medication use (prescription or non prescription medications, vitamins, herbals, dietary and mineral supplements and grapefruit products during or within 14 days prior to study participation; excludes contraceptives)
- History of addiction to drugs or alcohol (prior or present addiction or treatment for addiction)
- Pregnant or nursing female
- Lactose intolerance
- Smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School Of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Double Blind, Randomized, Single Dose, Placebo Controlled Study of the Pharmacokinetics and Side Effects of the mGlu5 Antagonist Fenobam in Adult Healthy Volunteers
This is a randomized, blinded, parallel group, placebo-controlled trial on 32 evaluable healthy male and non-pregnant female, 18-50 year old volunteers. The investigators goal is to observe the pharmacokinetics of fenobam after oral administration of 50, 100 or 150 mg in groups of healthy individuals and to compare the side effects and tolerability of a single dose of fenobam with placebo.
Read the detailed description
Treatment regimen 1: Fenobam [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate], oral administration of one 50 mg gelatin capsule.
Treatment regimen 2: Fenobam, oral administration of one 100 mg gelatin capsule.
Treatment regimen 3: Fenobam, oral administration of one 150 mg gelatin capsule.
Treatment regimen 4: Placebo (lactose), oral administration of one 150 mg gelatin capsule.
- Conditions
- Healthy
- Being tested
- Fenobam, Placebo
- Keywords
- Fenobam,, Pharmacokinetics, side effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenobamDrug
Also called N-(3-chlorophenyl)-N'-(4,5-dihydro-1-methyl-4-oxo-1H-imidazole-2-yl)urea
Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose)
PlaceboDrug
Also called Lactose
Oral administration of placebo or lactose 150 mg
| Study group | Role | What they receive |
|---|---|---|
| Fenobam 50 mg | Experimental | Treatment regimen 1: Fenobam [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate], oral administration of one 50 mg gelatin capsule. Receives: Drug: Fenobam |
| Fenobam 100 mg | Experimental | Treatment regimen 2: Fenobam, oral administration of one 100 mg gelatin capsule. Receives: Drug: Fenobam |
| Fenobam 150 mg | Experimental | Treatment regimen 3: Fenobam, oral administration of one 150 mg gelatin capsule. Receives: Drug: Fenobam |
| Placebo arm | Placebo comparator | Treatment regimen 4: Placebo (lactose), oral administration of one 150 mg gelatin capsule. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic data after oral administration of 50, 100 or 150 mg of fenobam in groups of healthy individuals.
Blood samples will be drawn periodically before and after fenobam/placebo administration for approximately 10 hours (at approximately 30, 60, 120, 180, 240, 300, 360 and 600 minutes) and one more time the next day (day 2).
Measured: 24 hours
Secondary outcomes (1)
Number of participants with adverse events as a measure of tolerability
Participants will be administered a questionnaire regarding side effects at the end of the study day, after administration of a single dose of 50 mg, 100 mg or 150 mg of fenobam, or 150 mg placebo. The questionnaire will be administered again the following day and one week after the study day. Side effects in the fenobam treatment groups will be compared to side effects in the placebo group.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Cavallone, Washington University School of Medicine
- Investigators
- Laura Cavallone, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806415
- Sponsor's protocol ID
- 201304126
- Status last verified
- Dec 2015
- First submitted
- 2 Mar 2013
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Single Dose, Placebo Controlled Study of the Pharmacokinetics and Side Effects of the mGlu5 Antagonist Fenobam in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01806415
- Acronym / sponsor ID
- 201304126
- Conditions
- Healthy
- Keywords
- Fenobam,, Pharmacokinetics, side effects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Mar 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 is a randomized, blinded, parallel group, placebo-controlled trial on 32 evaluable healthy male and non-pregnant female, 18-50 year old volunteers. The investigators goal is to observe the pharmacokinetics of fenobam after oral administration of 50, 100 or 150 mg in groups of healthy individuals and to compare the side effects and tolerability of a single dose of fenobam with placebo.
Detailed description
Treatment regimen 1: Fenobam [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate], oral administration of one 50 mg gelatin capsule.
Treatment regimen 2: Fenobam, oral administration of one 100 mg gelatin capsule.
Treatment regimen 3: Fenobam, oral administration of one 150 mg gelatin capsule.
Treatment regimen 4: Placebo (lactose), oral administration of one 150 mg gelatin capsule.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fenobam 50 mg | Experimental | Drug: FenobamTreatment regimen 1: Fenobam [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate], oral administration of one 50 mg gelatin capsule. |
| Fenobam 100 mg | Experimental | Drug: FenobamTreatment regimen 2: Fenobam, oral administration of one 100 mg gelatin capsule. |
| Fenobam 150 mg | Experimental | Drug: FenobamTreatment regimen 3: Fenobam, oral administration of one 150 mg gelatin capsule. |
| Placebo arm | Placebo comparator | Drug: PlaceboTreatment regimen 4: Placebo (lactose), oral administration of one 150 mg gelatin capsule. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-50 yr old
- Good general health with no remarkable medical conditions (e.g liver, kidney, heart, or lung failure), BMI<33 and no known drug allergies.
- Willing to comply with study guidelines as outlined in protocol
- Willing to provide informed consent.
Key exclusion criteria (5 listed)
- Medication use (prescription or non prescription medications, vitamins, herbals, dietary and mineral supplements and grapefruit products during or within 14 days prior to study participation; excludes contraceptives)
- History of addiction to drugs or alcohol (prior or present addiction or treatment for addiction)
- Pregnant or nursing female
- Lactose intolerance
- Smokers
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 |
|---|---|---|
| FenobamAlso: N-(3-chlorophenyl)-N'-(4,5-dihydro-1-methyl-4-oxo-1H-imidazole-2-yl)ureaOral administration of 50, 100, or 150mg of Fenobam or placebo (lactose) | Drug | Fenobam 100 mg, Fenobam 150 mg, Fenobam 50 mg |
| PlaceboAlso: LactoseOral administration of placebo or lactose 150 mg | Drug | Placebo arm |
Primary outcome
Pharmacokinetic data after oral administration of 50, 100 or 150 mg of fenobam in groups of healthy individuals.
Time frame: 24 hours
Blood samples will be drawn periodically before and after fenobam/placebo administration for approximately 10 hours (at approximately 30, 60, 120, 180, 240, 300, 360 and 600 minutes) and one more time the next day (day 2).
1 secondary outcome
Number of participants with adverse events as a measure of tolerability
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Laura Cavallone, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fenobam in people with Healthy, run by Washington University School of Medicine at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetic data after oral administration of 50, 100 or 150 mg of fenobam in groups of healthy individuals. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2015.