ObesityPhase 1/2PHACONCT02571959
Pharmacokinetic Study of the Association of Amoxicillin / Clavulanic Acid to Obese Adults
A Phase 1/2 study testing amoxicillin and clavulanic acid in people with Obesity, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 1 site in France.
Trial summary
Description of the pharmacokinetic parameters of the amoxicillin / clavulanic acid to healthy voluntary obese after oral and intra venous administration Determination of the pharmacokinetic parameters of amoxicillin / clavulanic acid obtained from plasmatic concentrations of intravenous injection (IV) and oral… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- amoxicillin and clavulanic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2015to 16 Jun 2017
- Phase
- Phase 1/2
- 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
- Voluntary obese
- Body mass index upper to 30 kg/m2
- Age from 18 to 65 years
- Signed free and lit consent
- Possible participation according to the national file of the volunteers of the French Ministry of Health.
- Volunteers affiliated to the Social Security
Who cannot join
- Pregnancy
- Evolutionary pregnancy or feeding
- Allergy in ß-lactamines (nettle rash, oedema of Quincke)
- Digestive intolerance with amoxicillin / clavulanic acid
- Infection by the virus of the HIV ( positive Ac anti HIV)
- Infection by the virus of the hepatitis B ( positive Ag Hbs)
Show all 25Show fewer
- Infection by the virus of the hepatitis C ( positive Ac anti VHC)
- Hepatic cirrhosis at the Child-Pugh C stage(stadium)
- Biological parameters:
- Polynucléaires neutrophiles 750 / mm3
- Haemoglobin 8g / dL
- Patellets 60 000 / mm3
- Creatinin clearance, according to MDRD, DFG 50 mL / min / 1,73m2
- ASAT or ALAT > 3 times the superior limit of the normal (LSN)
- Phosphatase alkaline > 3 LSN
- Total Bilirubine > 3 LSN
- Lipase > 3 LSN
- Factor V < 50 %
- Alcoholism chronicles (consumption superior to 30 g of alcohol a day, amount to 3 glasses of wine)
- Significant anomaly of the electrocardiogram, in particular QTc > 450 msec
- Subject susceptible not to respect the modalities of the study
- Drug addiction intra venous
- Any medical conditions which according to the judgment(sentence) of the investigator would may interfere with the moderate pharmacokinetic parameters
- People placed under legal protection
- Histories of bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Study of the Amoxicillin / Clavulanic Acid Association to Optimize Dosage Among Obese Adults (PHACO)
Description of the pharmacokinetic parameters of the amoxicillin / clavulanic acid to healthy voluntary obese after oral and intra venous administration Determination of the pharmacokinetic parameters of amoxicillin / clavulanic acid obtained from plasmatic concentrations of intravenous injection (IV) and oral administrations. The criterion of evaluation allowing to answer our main objective corresponds to the parameters estimated by the pharmacokinetic model of the concentrations obtained from the data IV and by the pharmacokinetic model of the concentrations obtained from the oral data. The following pharmacokinetic parameters will be considered at every obese volunteer's for both molecules (amoxicillin and clavulanic acid) from the concentrations by pharmacokinetic analysis of population.
The main evaluation criteria are PK parameters of amoxicillin / clavulanic:
- Cl, systematic plasmatic clearance
- Vd, volume of distribution
- ASC 0-oo, area under the curve time - concentration
- T1/2, half-life time
- F, bioavailability after oral administration
- Ka, constant of speed of absorption
Read the detailed description
Main objective Description of the pharmacokinetic parameters of the amoxicillin / clavulanic acid to healthy voluntary obese after oral and intra venous administration
Secondary objectives
- Define dosage plans optimized with the antibiotic treatment to the obese subject
- Ensure an adequacy of the treatment with the related infection
- Formulate recommendations of dosage adaptations for a better individualization of treatments, by estimating several plans of doses by simulation to reach various PK/PD goals according to different theoretical MIC
Methodology
The pharmacokinetic analysis will be realized by approach of population allowing the estimation of the average parameters of amoxicillin and clavulanic acid as well as the interpersonal variability after an administration IV and an oral administration. Parameters's population and their variability will be estimated with the SAEM algorithm implemented in the software Monolix ( www.lixoft.eu ).
For the main objective, PK parameters PK of amoxicillin and clavulanic acid will be determined to day 1 and day 2. They will be described by means of indicators of position (average and median) and of dispersal (standard deviations, quartiles).
For secondary objectives, the profiles concentration/time of 1000 obese subjects will be determined by Monte Carlo method from PK parameters estimated at the balance by the model. For every feigned profile, the time during which the plasmatic concentration of amoxicillin and clavulanic acid is superior to a panel of theoretical MIC will be calculated by means of curves concentration - time determined for each of the subjects.
- Conditions
- Obesity
- Being tested
- amoxicillin and clavulanic acid
- Keywords
- Obesity, Pharmacology, Amoxicillin-Potassium Clavulanate Combination
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillin and clavulanic acidDrug
Also called AMOXICILLINE / acide clavulonique SANDOZ
Day 1 : a dose of amoxicillin and clavulanic acid 1g / 200mg will be intravenously administered
amoxicillin and clavulanic acidDrug
Also called AMOXICILLINE / acide clavulonique SANDOZ
Day 2 : a dose of amoxicillin and clavulanic acid 1g / 125mg will be administered by oral route
| Study group | Role | What they receive |
|---|---|---|
| amoxicillin and clavulanic acid | Experimental | All volunteers receive a dose of amoxicillin and clavulanic acid Receives: Drug: amoxicillin and clavulanic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systematic plasmatic clearance (Cl)
Measured: 1 day
Secondary outcomes (5)
Area under the curve time - concentration (AUC 0-oo)
Measured: 1 day
Half-life time (T1/2)
Measured: 1 day
Volume of distribution (Vd)
Measured: 1 day
Bioavailability after oral administration (F)
Measured: 1 day
Constant of speed of absorption (Ka)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study start24 Jul 2015
- Primary completion13 Oct 2015
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571959
- Sponsor's protocol ID
- IMEA 046
- Acronym
- PHACO
- Status last verified
- Jan 2018
- First submitted
- 14 Apr 2015
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of the Amoxicillin / Clavulanic Acid Association to Optimize Dosage Among Obese Adults (PHACO)
- ClinicalTrials.gov ID
- NCT02571959
- Acronym / sponsor ID
- PHACO / IMEA 046
- Conditions
- Obesity
- Keywords
- Obesity, Pharmacology, Amoxicillin-Potassium Clavulanate Combination
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'BaUniversity, hospital or other
- Study start
- 24 Jul 2015 (actual)
- Primary completion
- 13 Oct 2015 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 8 Oct 2015 (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.
Description of the pharmacokinetic parameters of the amoxicillin / clavulanic acid to healthy voluntary obese after oral and intra venous administration Determination of the pharmacokinetic parameters of amoxicillin / clavulanic acid obtained from plasmatic concentrations of intravenous injection (IV) and oral administrations. The criterion of evaluation allowing to answer our main objective corresponds to the parameters estimated by the pharmacokinetic model of the concentrations obtained from the data IV and by the pharmacokinetic model of the concentrations obtained from the oral data. The following pharmacokinetic parameters will be considered at every obese volunteer's for both molecules (amoxicillin and clavulanic acid) from the concentrations by pharmacokinetic analysis of population.
The main evaluation criteria are PK parameters of amoxicillin / clavulanic:
- Cl, systematic plasmatic clearance
- Vd, volume of distribution
- ASC 0-oo, area under the curve time - concentration
- T1/2, half-life time
- F, bioavailability after oral administration
- Ka, constant of speed of absorption
Detailed description
Main objective Description of the pharmacokinetic parameters of the amoxicillin / clavulanic acid to healthy voluntary obese after oral and intra venous administration
Secondary objectives
- Define dosage plans optimized with the antibiotic treatment to the obese subject
- Ensure an adequacy of the treatment with the related infection
- Formulate recommendations of dosage adaptations for a better individualization of treatments, by estimating several plans of doses by simulation to reach various PK/PD goals according to different theoretical MIC
Methodology
The pharmacokinetic analysis will be realized by approach of population allowing the estimation of the average parameters of amoxicillin and clavulanic acid as well as the interpersonal variability after an administration IV and an oral administration. Parameters's population and their variability will be estimated with the SAEM algorithm implemented in the software Monolix ( www.lixoft.eu ).
For the main objective, PK parameters PK of amoxicillin and clavulanic acid will be determined to day 1 and day 2. They will be described by means of indicators of position (average and median) and of dispersal (standard deviations, quartiles).
For secondary objectives, the profiles concentration/time of 1000 obese subjects will be determined by Monte Carlo method from PK parameters estimated at the balance by the model. For every feigned profile, the time during which the plasmatic concentration of amoxicillin and clavulanic acid is superior to a panel of theoretical MIC will be calculated by means of curves concentration - time determined for each of the subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| amoxicillin and clavulanic acid | Experimental | Drug: amoxicillin and clavulanic acidAll volunteers receive a dose of amoxicillin and clavulanic acid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary obese
- Body mass index upper to 30 kg/m2
- Age from 18 to 65 years
- Signed free and lit consent
- Possible participation according to the national file of the volunteers of the French Ministry of Health.
Key exclusion criteria (25 listed)
- Pregnancy
- Evolutionary pregnancy or feeding
- Allergy in ß-lactamines (nettle rash, oedema of Quincke)
- Digestive intolerance with amoxicillin / clavulanic acid
- Infection by the virus of the HIV ( positive Ac anti HIV)
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 |
|---|---|---|
| amoxicillin and clavulanic acidAlso: AMOXICILLINE / acide clavulonique SANDOZDay 1 : a dose of amoxicillin and clavulanic acid 1g / 200mg will be intravenously administered | Drug | amoxicillin and clavulanic acid |
| amoxicillin and clavulanic acidAlso: AMOXICILLINE / acide clavulonique SANDOZDay 2 : a dose of amoxicillin and clavulanic acid 1g / 125mg will be administered by oral route | Drug | amoxicillin and clavulanic acid |
Primary outcome
Systematic plasmatic clearance (Cl)
Time frame: 1 day
5 secondary outcomes
Area under the curve time - concentration (AUC 0-oo)
Time frame: 1 day
Half-life time (T1/2)
Time frame: 1 day
Volume of distribution (Vd)
Time frame: 1 day
Bioavailability after oral administration (F)
Time frame: 1 day
Constant of speed of absorption (Ka)
Time frame: 1 day
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 12 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing amoxicillin and clavulanic acid in people with Obesity, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 1 site in France.
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 25 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 12 Jan 2018. 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 France. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Systematic plasmatic clearance (Cl) (time frame: 1 day). 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 12 Jan 2018.