Plasma ConcentrationEarly Phase 1NCT02025348
Explore the Performance of IntelliCap.
A Early Phase 1 study testing IntelliCap in people with Plasma Concentration and Pharmacokinetic Profile, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This is an open-label, randomised, 4-way crossover study in twelve healthy male volunteers. The study will characterise the performance of IntelliCap® by evaluating the plasma concentration and pharmacokinetic profile of a probe drug (IMP; metoprolol) released from IntelliCap® with three different release profiles and… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Plasma Concentration, Pharmacokinetic Profile
- What is being tested?
- IntelliCap
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Mar 2014
- Phase
- Early 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged between 18 and 50 years of age, inclusive.
- Subjects with a body weight of at least 50 kg and no more than 100 kg, inclusive.
- Subjects with a body mass index (BMI) of 18 - 30 kg/m2, inclusive. BMI = Body weight (kg) / [Height (m)]2.
- Subjects with suitable veins for cannulation or repeated venepuncture.
- Subjects must be available to complete the study.
- Subjects must satisfy a medical examiner about their fitness to participate in the study.
- Subjects must provide written informed consent to participate in the study.
Who cannot join
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Abnormal vital signs, after 10 min supine rest, defined as any of the following:
- Systolic blood pressure < 100 mmHg or ≥ 140 mmHg.
- Diastolic blood pressure < 50 mmHg or ≥ 90 mmHg.
- Heart rate < 50 or > 85 beats per minute.
- Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG.
Show all 13Show fewer
- History of severe allergy/hypersensitivity or on-going clinically important allergy/ hypersensitivity as judged by the Investigator or known hypersensitivity to metoprolol (including other beta-blockers) or any other component of the product.
- •Plasma donation within one month of screening or any blood donation/blood loss greater than 500 mL during the three (3) months prior to screening.
- Receipt of a new chemical entity (defined as a compound which has not been approved for marketing) or participation in any other clinical study that includes drug treatment within at least three (3) months of the first administration of study treatment in this study. The period of exclusion begins three months after the final dose. Note: subjects consented and screened, but not randomised in this study or a previous phase I study, are not excluded.
- Previous randomisation to treatment in the present study.
- Involvement of any CRO/third party contractor or AZ employee and their close relatives regardless of their role.
- Judgement by the Investigator that the subject should not participate in the study if they have any on-going or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.
- Subjects who cannot communicate reliably with the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Open-label, 4-way Crossover Study in Healthy Subjects to Explore the Performance of IntelliCap® by Comparing Pharmacokinetic Profiles of a Probe Drug.
This is an open-label, randomised, 4-way crossover study in twelve healthy male volunteers.
The study will characterise the performance of IntelliCap® by evaluating the plasma concentration and pharmacokinetic profile of a probe drug (IMP; metoprolol) released from IntelliCap® with three different release profiles and the plasma concentration and pharmacokinetic profile of the same probe drug after a single dose of an oral solution.
- Conditions
- Plasma Concentration, Pharmacokinetic Profile
- Being tested
- IntelliCap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntelliCapDrug
Also called IntelliCap and metoprolol
Drug release from the IntelliCap® system will be actuated post-gastric emptying of IntelliCap® capsule.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A metoprolol 50mg | Experimental | IntelliCap® capsule Release profile 1 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg). Receives: Drug: IntelliCap |
| Treatment B metoprolol 50mg | Experimental | IntelliCap® capsule Release profile 2 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg). Receives: Drug: IntelliCap |
| Treatment C metoprolol 50mg | Experimental | IntelliCap® capsule Release profile 3 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg). Receives: Drug: IntelliCap |
| Treatment D metorpolol 50mg | Experimental | metoprolol oral solution 1 mg/mL (dose 50 mg). Receives: Drug: IntelliCap |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vivo performance
To assess the in vivo performance of the IntelliCap® system by characterizing the plasma concentration of a probe drug (metoprolol)
Measured: Pre-dose, pre-actuation (except in study period when subjects are dosed with oral solution) , 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 14 h, 24 h, 28 h, and 32 h
Secondary outcomes (1)
Pharmacokinetic parameters
To determine the pharmacokinetic parameters of a probe drug (metoprolol), by assessment of AUC0-t, AUC0-∞, Cmax, tmax, t1/2 and Vz/F.
Measured: Pre-dose, pre-actuation (except in study period when subjects are dosed with oral solution) , 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 14 h, 24 h, 28 h, and 32 h.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma ConcentrationStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salvatore Febbraro, MD PhD, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025348
- Sponsor's protocol ID
- D1840M00044
- Status last verified
- Jan 2016
- First submitted
- 20 Dec 2013
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label, 4-way Crossover Study in Healthy Subjects to Explore the Performance of IntelliCap® by Comparing Pharmacokinetic Profiles of a Probe Drug.
- ClinicalTrials.gov ID
- NCT02025348
- Acronym / sponsor ID
- D1840M00044
- Conditions
- Plasma Concentration, Pharmacokinetic Profile
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Jan 2014 (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 an open-label, randomised, 4-way crossover study in twelve healthy male volunteers.
The study will characterise the performance of IntelliCap® by evaluating the plasma concentration and pharmacokinetic profile of a probe drug (IMP; metoprolol) released from IntelliCap® with three different release profiles and the plasma concentration and pharmacokinetic profile of the same probe drug after a single dose of an oral solution.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A metoprolol 50mg | Experimental | Drug: IntelliCapIntelliCap® capsule Release profile 1 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg). |
| Treatment B metoprolol 50mg | Experimental | Drug: IntelliCapIntelliCap® capsule Release profile 2 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg). |
| Treatment C metoprolol 50mg | Experimental | Drug: IntelliCapIntelliCap® capsule Release profile 3 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg). |
| Treatment D metorpolol 50mg | Experimental | Drug: IntelliCapmetoprolol oral solution 1 mg/mL (dose 50 mg). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male volunteers aged between 18 and 50 years of age, inclusive.
- Subjects with a body weight of at least 50 kg and no more than 100 kg, inclusive.
- Subjects with a body mass index (BMI) of 18 - 30 kg/m2, inclusive. BMI = Body weight (kg) / [Height (m)]2.
- Subjects with suitable veins for cannulation or repeated venepuncture.
- Subjects must be available to complete the study.
Key exclusion criteria (13 listed)
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Abnormal vital signs, after 10 min supine rest, defined as any of the following:
- Systolic blood pressure < 100 mmHg or ≥ 140 mmHg.
- Diastolic blood pressure < 50 mmHg or ≥ 90 mmHg.
- Heart rate < 50 or > 85 beats per minute.
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 |
|---|---|---|
| IntelliCapAlso: IntelliCap and metoprololDrug release from the IntelliCap® system will be actuated post-gastric emptying of IntelliCap® capsule. | Drug | Treatment A metoprolol 50mg, Treatment B metoprolol 50mg, Treatment C metoprolol 50mg, Treatment D metorpolol 50mg |
Primary outcome
In vivo performance
Time frame: Pre-dose, pre-actuation (except in study period when subjects are dosed with oral solution) , 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 14 h, 24 h, 28 h, and 32 h
To assess the in vivo performance of the IntelliCap® system by characterizing the plasma concentration of a probe drug (metoprolol)
1 secondary outcome
Pharmacokinetic parameters
Time frame: Pre-dose, pre-actuation (except in study period when subjects are dosed with oral solution) , 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 14 h, 24 h, 28 h, and 32 h.
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 27 Jan 2016.
- D1840M00044\_CSR\_SynopsisLink provided by the sponsor.
- PublicationLink provided by the sponsor.
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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.
Salvatore Febbraro, MD PhD principal investigator
Simbec Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IntelliCap in people with Plasma Concentration and Pharmacokinetic Profile, run by AstraZeneca at 1 site in United Kingdom.
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 7 inclusion and 13 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 27 Jan 2016. 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 Kingdom. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
In vivo performance (time frame: Pre-dose, pre-actuation (except in study period when subjects are dosed with oral solution) , 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 14 h, 24 h, 28 h, and 32 h). 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 27 Jan 2016.