HealthyPhase 1NCT00791817
Study to Evaluate Potential Food Effects
A Phase 1 study testing PG-760564 in people with Healthy, run by Procter and Gamble at 1 site in United States.
Trial summary
Half the group will be given a high fat diet and the other half will fast. They will then be crossed over. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PG-760564
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jan 2006
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and surgically sterile or post-menopausal (last menstrual period > 1 year at the time of enrollment) healthy females, 18-45 years of age, inclusive, at screening;
- Who have not used tobacco or nicotine-containing products within the past 3 months;
- Willing to abstain from caffeine or xanthine-containing beverages, including coffee and tea, chocolate, alcohol, grapefruit juice, and Seville oranges, from 24 hours before admission and for the duration of the study;
- Who have a body mass index (BMI) between 18 and 32 kg/m2, inclusive.
Who cannot join
- History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;
- History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;
- History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding;
- History of autoimmune disease;
- History of immunodeficiency or of unusual susceptibility to infectious diseases;
- History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV);
Show all 18Show fewer
- Any history of hypersensitivity or clinically significant allergy to any drug;
- Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality;
- Family history of sudden death;
- History of uveitis or inflammatory ocular disease;
- History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding;
- History of autoimmune disease;
- History of immunodeficiency or of unusual susceptibility to infectious diseases;
- History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV);
- Any history of hypersensitivity or clinically significant allergy to any drug;
- Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality;
- Family history of sudden death;
- History of uveitis or inflammatory ocular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single Dose, Randomized, Crossover Study to Evaluate Potential Food Effects
Half the group will be given a high fat diet and the other half will fast. They will then be crossed over.
Read the detailed description
A food-effect study which will be conducted at any time during the MRD study period on one single cohort of subjects using 200 mg oral dose of PG 760564. Half the group will be given a high fat diet and the other half will fast. They will ten be crossed over.
- Conditions
- Healthy
- Being tested
- PG-760564
- Keywords
- pharmacokinetics study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG-760564Drug
200 mg capsule, single dose,fasted when dosed, duration is 4 days
PG-760564Drug
200 mg capsule, single dose,high fat diet when dosed, duration is 4 days
| Study group | Role | What they receive |
|---|---|---|
| 200 mg PG 760564, Subjects Fasted | Experimental | 200 mg PG 760564, Subjects Fasted, single dose Receives: Drug: PG-760564 |
| 200 mg PG 760564, Subjects Fed | Experimental | 200 mg PG 760564, Subjects Fed high fat meal Receives: Drug: PG-760564 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration after a single dose
Measured: over 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startAug 2005
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William S Aronstein, MD, PhD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791817
- Sponsor's protocol ID
- 2005046B
- Status last verified
- Aug 2011
- First submitted
- 13 Nov 2008
- Last updated
- 7 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Dose, Randomized, Crossover Study to Evaluate Potential Food Effects
- ClinicalTrials.gov ID
- NCT00791817
- Acronym / sponsor ID
- 2005046B
- Conditions
- Healthy
- Keywords
- pharmacokinetics study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Posted 7 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Half the group will be given a high fat diet and the other half will fast. They will then be crossed over.
Detailed description
A food-effect study which will be conducted at any time during the MRD study period on one single cohort of subjects using 200 mg oral dose of PG 760564. Half the group will be given a high fat diet and the other half will fast. They will ten be crossed over.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 200 mg PG 760564, Subjects Fasted | Experimental | Drug: PG-760564200 mg PG 760564, Subjects Fasted, single dose |
| 200 mg PG 760564, Subjects Fed | Experimental | Drug: PG-760564200 mg PG 760564, Subjects Fed high fat meal |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males and surgically sterile or post-menopausal (last menstrual period > 1 year at the time of enrollment) healthy females, 18-45 years of age, inclusive, at screening;
- Who have not used tobacco or nicotine-containing products within the past 3 months;
- Willing to abstain from caffeine or xanthine-containing beverages, including coffee and tea, chocolate, alcohol, grapefruit juice, and Seville oranges, from 24 hours before admission and for the duration of the study;
- Who have a body mass index (BMI) between 18 and 32 kg/m2, inclusive.
Key exclusion criteria (18 listed)
- History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;
- History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;
- History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding;
- History of autoimmune disease;
- History of immunodeficiency or of unusual susceptibility to infectious diseases;
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 |
|---|---|---|
| PG-760564200 mg capsule, single dose,fasted when dosed, duration is 4 days | Drug | 200 mg PG 760564, Subjects Fasted |
| PG-760564200 mg capsule, single dose,high fat diet when dosed, duration is 4 days | Drug | 200 mg PG 760564, Subjects Fed |
Primary outcome
Cmax
Time frame: over 12 hours
Maximum plasma concentration after a single dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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.
William S Aronstein, MD, PhD study director
Procter and Gamble
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 PG-760564 in people with Healthy, run by Procter and Gamble 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 18 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 7 Sep 2011. 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. 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?
Yes. Results are posted in the registry (first posted 7 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax (time frame: over 12 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 7 Sep 2011.