HealthyPhase 1NCT04080713
Cortiment® MMX Pharmacokinetic Study
A Phase 1 study testing Budesonide in people with Healthy, run by Ferring Pharmaceuticals at 1 site in India.
Trial summary
Budesonide is a well-known and well-characterised locally acting glucocorticosteroid with comparable efficacy to that of conventional glucocorticosteroids, but with fewer systemic side effects due to its low bioavailability following oral administration. 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?
- Budesonide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 16 Sep 2019to 25 Sep 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Indian men and women between18-45 (both inclusive) years of age (at the time of signed/ thumb impression informed consent).
- Body mass index (BMI) between 18.5 kg/m^2 and 29.9 kg/m^2 (both inclusive) and body weight between 50 kg and 100 kg.
- Negative hepatitis screen including hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibodies at screening.
- Negative test result for human immunodeficiency virus (HIV) (I and II) antibody.
- Healthy according to medical history (including surgical history), physical examination, 12-lead ECG, chest X-ray recordings (postero-anterior view), vital sign (sitting blood pressure, pulse rate and body temperature), and laboratory profile of blood and urine at screening.
- Negative serum pregnancy test (for females) at screening and on Day -1.
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- Regular intestinal function; no constipation and no diarrhea.
- Has given written informed consent prior to any study-related activity is performed.
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study.
- Negative alcohol test, urine drug screen test on the day of screening and the day before dosing.
- Non-smokers.
- Agree to use double-barrier contraception or intra-uterine device, intra-uterine system, combined oral contraceptive pill associated with inhibition of ovulation (oral, intravaginal, transdermal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) during the study if not abstinent. Previous surgical sterilization of subject or their sexual partner (bilateral tubal ligation, vasectomy) also represents a permissible form of contraception. Methods of double barrier contraception include use of the male condom together with female condom or cervical cap or diaphragm.
Who cannot join
- Allergy: Ascertained or presumptive hypersensitivity to the active principle, lecithin (derived from soya oil, peanut oil) and/or other formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study.
- Diseases: Presence or relevant history of renal, hepatic, gastrointestinal (GI), cardiovascular, haematological, respiratory or any other body system, any recent or ongoing infections or endocrine or neurologic diseases that may interfere with the aim of the study. Particularly, history of GI diseases, inflammatory bowel disease (IBD), intolerance to lactose; neoplasias.
- Medications: medication, including over-the-counter (OTC) and CYP3A4 inducers/inhibitors or herbal medication, during 2 weeks or five half-lives of the drug, whichever is longer, prior to screening; in particular, drugs affecting GI physiology. Allowed medications included acetaminophen/paracetamol and cromoglycate eye drops according to label, hormonal contraceptives for fertile women.
- Previous or current budesonide treatment.
- Use of live vaccine within 4 weeks prior to dosing.
- Life style: history (within the last two years) or present abuse of drug, alcohol [defined as regular intake of more than 14 units weekly for men /7 units weekly for women - one unit of alcohol equals about 300 mL of beer or lager, one glass (100 mL) of wine, or 25 mL spirits].
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- Current smokers or subjects who have smoked within last six months prior to start of the study.
- Consumption of Grapefruits or its products within a period of one-week prior to receiving the study drug.
- Consumption of poppy seeds (e.g., poppy cake) and betel nuts at least seven days at least seven days before receiving the trial drug.
- A high daily consumption of caffeine-containing beverages (e.g., more than five cups of coffee or equivalent) with a risk of withdrawal. symptoms arising during the study that may have confounded the safety evaluation.
- Female subjects who are pregnant, breastfeeding or intend to become pregnant.
- Any medical or surgical condition that may interfere with the absorption, distribution, metabolism, or excretion of the drug, as judged by the investigator.
- Acute illness within two weeks prior to screening.
- Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication.
- If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
- A mental condition, the lack of decision-making ability, dementia or a speech handicap, which, in the judgement of the Investigator, would impair the participation of the subjects in the study.
- Any other reasons, which will make clinical study participation inappropriate with the decision of the investigator.
- The presence of clinically significant abnormal laboratory values during screening.
- Difficulty in swallowing solids dosage forms like tablets or capsules.
- Previous participation in a budesonide study.
- History of diabetes and/or hyperglycemia.
- History of menstrual disturbances (for females).
- History of hypercorticism.
- History of ophthalmological disorders (e.g. glaucoma).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Study Investigating the Pharmacokinetic Profile and Safety of Single Oral Dose of Budesonide Prolonged Release Tablets 9mg (Cortiment® MMX) in Healthy Indian Subjects Under Fasting Condition
Budesonide is a well-known and well-characterised locally acting glucocorticosteroid with comparable efficacy to that of conventional glucocorticosteroids, but with fewer systemic side effects due to its low bioavailability following oral administration.
There are no benefits for subjects participating in this pharmacokinetic (PK) profile and safety study. This is an open-label study to investigate the PK profile and safety of single oral dose of budesonide prolonged release tablets (9 mg, Cortiment® MMX [multi-matrix system]) in healthy subjects in Indian population.
Read more
Two study visits are planned: One out-patient visit (screening) and one residential session consisting of three consecutive nights (admission to the clinical investigation unit at least 12 hours before dosing and discharge approximately 60 hours after dosing). End-of-study assessments will be performed before discharge from the clinical investigation unit in the single dosing period. Subjects should be in the fasted state for at least 10 hours pre-dose.
Number of subjects planned in total in the study are 24 men and women, with a minimum requirement of 7 women. The safety assessments comprise of adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory variables. Adverse events will be collected throughout the study.
- Conditions
- Healthy
- Being tested
- Budesonide
- Keywords
- Budesonide, Healthy, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Also called Cortiment® MMX
Budesonide 9 mg prolonged release tablet
| Study group | Role | What they receive |
|---|---|---|
| Budesonide | Experimental | Not described Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Maximum plasma concentration observed (Cmax)
Measured: Up to 60 hours post-dose
Pharmacokinetics: Pharmacokinetic lag time (Tlag)
Tlag is defined as the time of observation prior to the first observation with a measurable (non-zero) concentration.
Measured: Up to 60 hours post-dose
Pharmacokinetics: Time of maximum observed plasma concentration (Tmax)
Measured: Up to 60 hours post-dose
Pharmacokinetics: Area under the plasma concentration-time curve from time zero up to time t (AUCt)
AUCt is defined as the area under the plasma concentration-time curve from time zero up to time t, where t is the last time point at which the concentration is above the lower limit of quantification (time of last measurable [non-zero] concentration [tlast]).
Measured: Up to 60 hours post-dose
Pharmacokinetics: Area under the plasma concentration-time curve to infinity (AUCinf)
Measured: Up to 60 hours post-dose
Pharmacokinetics: %Extrap AUC
%Extrap AUC is defined as the percentage of AUC that is due to extrapolation from the last measurable concentration.
Measured: Up to 60 hours post-dose
Pharmacokinetics: Terminal half-life (t1/2)
Measured: Up to 60 hours post-dose
Pharmacokinetics: Terminal elimination rate constant (λz)
λz is defined as the first-order rate constant associated with terminal (log-linear) portion of the plasma concentration-time curve estimated via linear regression of the time versus log concentration.
Measured: Up to 60 hours post-dose
Pharmacokinetics: Apparent total systemic clearance (CL/F)
Measured: Up to 60 hours post-dose
Pharmacokinetics: Apparent volume of distribution associated with the terminal phase (VZ/F)
Measured: Up to 60 hours post-dose
Pharmacokinetics: Mean residence time (MRT)
Measured: Up to 60 hours post-dose
Number of subjects with adverse events (AEs) and type of adverse events
An AE is defined as any untoward medical occurrence in a subject taking part in a clinical study. Number of subjects with any AE (serious or non-serious) are presented.
Measured: From screening (Day-28 to Day -1) up to the end-of-study (Day 3)
Number of subjects with abnormal laboratory parameters
Number of subjects with abnormal findings in laboratory parameters (biochemistry, hematology, and urine analysis) will be presented.
Measured: From screening (Day-28 to Day -1) up to the end-of-study (Day 3)
Number of subjects with abnormal vital signs
Number of subjects with abnormal findings in vital signs will be presented.
Measured: From screening (Day-28 to Day -1) up to the end-of-study (Day 3)
Number of subjects with abnormal changes in ECG
Number of subjects with abnormal findings in ECG will be presented.
Measured: From screening (Day-28 to Day -1) up to the end-of-study (Day 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start16 Sep 2019
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080713
- Sponsor's protocol ID
- 000326
- Status last verified
- Oct 2019
- First submitted
- 4 Sep 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study Investigating the Pharmacokinetic Profile and Safety of Single Oral Dose of Budesonide Prolonged Release Tablets 9mg (Cortiment® MMX) in Healthy Indian Subjects Under Fasting Condition
- ClinicalTrials.gov ID
- NCT04080713
- Acronym / sponsor ID
- 000326
- Conditions
- Healthy
- Keywords
- Budesonide, Healthy, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 6 Sep 2019 (actual)
- 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.
Budesonide is a well-known and well-characterised locally acting glucocorticosteroid with comparable efficacy to that of conventional glucocorticosteroids, but with fewer systemic side effects due to its low bioavailability following oral administration.
There are no benefits for subjects participating in this pharmacokinetic (PK) profile and safety study. This is an open-label study to investigate the PK profile and safety of single oral dose of budesonide prolonged release tablets (9 mg, Cortiment® MMX [multi-matrix system]) in healthy subjects in Indian population.
Two study visits are planned: One out-patient visit (screening) and one residential session consisting of three consecutive nights (admission to the clinical investigation unit at least 12 hours before dosing and discharge approximately 60 hours after dosing). End-of-study assessments will be performed before discharge from the clinical investigation unit in the single dosing period. Subjects should be in the fasted state for at least 10 hours pre-dose.
Number of subjects planned in total in the study are 24 men and women, with a minimum requirement of 7 women. The safety assessments comprise of adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory variables. Adverse events will be collected throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Experimental | Drug: Budesonide |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy Indian men and women between18-45 (both inclusive) years of age (at the time of signed/ thumb impression informed consent).
- Body mass index (BMI) between 18.5 kg/m^2 and 29.9 kg/m^2 (both inclusive) and body weight between 50 kg and 100 kg.
- Negative hepatitis screen including hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibodies at screening.
- Negative test result for human immunodeficiency virus (HIV) (I and II) antibody.
- Healthy according to medical history (including surgical history), physical examination, 12-lead ECG, chest X-ray recordings (postero-anterior view), vital sign (sitting blood pressure, pulse rate and body temperature), and laboratory profile of blood and urine at screening.
Key exclusion criteria (25 listed)
- Allergy: Ascertained or presumptive hypersensitivity to the active principle, lecithin (derived from soya oil, peanut oil) and/or other formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study.
- Diseases: Presence or relevant history of renal, hepatic, gastrointestinal (GI), cardiovascular, haematological, respiratory or any other body system, any recent or ongoing infections or endocrine or neurologic diseases that may interfere with the aim of the study. Particularly, history of GI diseases, inflammatory bowel disease (IBD), intolerance to lactose; neoplasias.
- Medications: medication, including over-the-counter (OTC) and CYP3A4 inducers/inhibitors or herbal medication, during 2 weeks or five half-lives of the drug, whichever is longer, prior to screening; in particular, drugs affecting GI physiology. Allowed medications included acetaminophen/paracetamol and cromoglycate eye drops according to label, hormonal contraceptives for fertile women.
- Previous or current budesonide treatment.
- Use of live vaccine within 4 weeks prior to dosing.
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 |
|---|---|---|
| BudesonideAlso: Cortiment® MMXBudesonide 9 mg prolonged release tablet | Drug | Budesonide |
Primary outcome
Pharmacokinetics: Maximum plasma concentration observed (Cmax)
Time frame: Up to 60 hours post-dose
Pharmacokinetics: Pharmacokinetic lag time (Tlag)
Time frame: Up to 60 hours post-dose
Tlag is defined as the time of observation prior to the first observation with a measurable (non-zero) concentration.
Pharmacokinetics: Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 60 hours post-dose
Pharmacokinetics: Area under the plasma concentration-time curve from time zero up to time t (AUCt)
Time frame: Up to 60 hours post-dose
AUCt is defined as the area under the plasma concentration-time curve from time zero up to time t, where t is the last time point at which the concentration is above the lower limit of quantification (time of last measurable [non-zero] concentration [tlast]).
Pharmacokinetics: Area under the plasma concentration-time curve to infinity (AUCinf)
Time frame: Up to 60 hours post-dose
Pharmacokinetics: %Extrap AUC
Time frame: Up to 60 hours post-dose
%Extrap AUC is defined as the percentage of AUC that is due to extrapolation from the last measurable concentration.
Pharmacokinetics: Terminal half-life (t1/2)
Time frame: Up to 60 hours post-dose
Pharmacokinetics: Terminal elimination rate constant (λz)
Time frame: Up to 60 hours post-dose
λz is defined as the first-order rate constant associated with terminal (log-linear) portion of the plasma concentration-time curve estimated via linear regression of the time versus log concentration.
Pharmacokinetics: Apparent total systemic clearance (CL/F)
Time frame: Up to 60 hours post-dose
Pharmacokinetics: Apparent volume of distribution associated with the terminal phase (VZ/F)
Time frame: Up to 60 hours post-dose
Pharmacokinetics: Mean residence time (MRT)
Time frame: Up to 60 hours post-dose
Number of subjects with adverse events (AEs) and type of adverse events
Time frame: From screening (Day-28 to Day -1) up to the end-of-study (Day 3)
An AE is defined as any untoward medical occurrence in a subject taking part in a clinical study. Number of subjects with any AE (serious or non-serious) are presented.
Number of subjects with abnormal laboratory parameters
Time frame: From screening (Day-28 to Day -1) up to the end-of-study (Day 3)
Number of subjects with abnormal findings in laboratory parameters (biochemistry, hematology, and urine analysis) will be presented.
Number of subjects with abnormal vital signs
Time frame: From screening (Day-28 to Day -1) up to the end-of-study (Day 3)
Number of subjects with abnormal findings in vital signs will be presented.
Number of subjects with abnormal changes in ECG
Time frame: From screening (Day-28 to Day -1) up to the end-of-study (Day 3)
Number of subjects with abnormal findings in ECG will be presented.
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 21 Oct 2019.
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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.
Global Clinical Compliance study director
Ferring Pharmaceuticals
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 Budesonide in people with Healthy, run by Ferring Pharmaceuticals at 1 site in India.
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 12 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 21 Oct 2019. 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 India. 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?
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?
Pharmacokinetics: Maximum plasma concentration observed (Cmax) (time frame: Up to 60 hours post-dose). The study lists 15 primary outcomes in all. 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 21 Oct 2019.