HealthyPhase 1NCT02183480
Dose Proportionality of Different Dose Strengths of Linagliptin Tablets After Oral Administration to Healthy Male and Female Volunteers
A Phase 1 study testing Linagliptin, low dose, Linagliptin, medium dose and Linagliptin, high dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to assess the pharmacokinetics and dose proportionality of 1 mg, 2.5 mg and 5 mg tablets of linagliptin Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Linagliptin, low dose, Linagliptin, medium dose and Linagliptin, high dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Sep 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests
- Age 18 to 55 years (inclusive)
- BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (inclusive)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Who cannot join
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
Show all 20Show fewer
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration except if a relevant interaction can be ruled out
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Alcohol abuse ( average consumption of more than 20 g/day in females and 30 g/day in males)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- For female subjects only:
- Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
- No adequate contraception during the study and until 1 month after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, IUD (intrauterine device), sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide)
- Lactation
About this study
Official title: Assessment of Dose Proportionality of Different Dose Strengths of Linagliptin Tablets After Oral Administration to Healthy Male and Female Volunteers in an Open, Randomised, Multiple-dose, Three-period Crossover, Phase I Trial
Study to assess the pharmacokinetics and dose proportionality of 1 mg, 2.5 mg and 5 mg tablets of linagliptin
- Conditions
- Healthy
- Being tested
- Linagliptin, low dose, Linagliptin, medium dose, Linagliptin, high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linagliptin, low doseDrug
Linagliptin, medium doseDrug
Linagliptin, high doseDrug
| Study group | Role | What they receive |
|---|---|---|
| Linagliptin, low dose | Experimental | Not described Receives: Drug: Linagliptin, low dose |
| Linagliptin, medium dose | Experimental | Not described Receives: Drug: Linagliptin, medium dose |
| Linagliptin, high dose | Active comparator | Not described Receives: Drug: Linagliptin, high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of linagliptin
Measured: up to 168 hours after first drug administration at each visit
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of linagliptin
Measured: up to 168 hours after first drug administration at each visit
Cτ,ss (average measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of linagliptin
Measured: up to 168 hours after first drug administration at each visit
Secondary outcomes (4)
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1750
Measured: up to 168 hours after first drug administration at each visit
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1750
Measured: up to 168 hours after first drug administration at each visit
Number of patients with adverse events
Measured: up to 53 days
Assessment of tolerability by investigator on a 4-point scale
Measured: within 10 days after last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJul 2009
- Primary completionSep 2009
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 Boehringer IngelheimThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183480
- Sponsor's protocol ID
- 1218.33
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dose Proportionality of Different Dose Strengths of Linagliptin Tablets After Oral Administration to Healthy Male and Female Volunteers in an Open, Randomised, Multiple-dose, Three-period Crossover, Phase I Trial
- ClinicalTrials.gov ID
- NCT02183480
- Acronym / sponsor ID
- 1218.33
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Sep 2009 (actual)
- First posted
- 8 Jul 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.
Study to assess the pharmacokinetics and dose proportionality of 1 mg, 2.5 mg and 5 mg tablets of linagliptin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Linagliptin, low dose | Experimental | Drug: Linagliptin, low dose |
| Linagliptin, medium dose | Experimental | Drug: Linagliptin, medium dose |
| Linagliptin, high dose | Active comparator | Drug: Linagliptin, high dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests
- Age 18 to 55 years (inclusive)
- BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (inclusive)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Key exclusion criteria (20 listed)
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
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 |
|---|---|---|
| Linagliptin, low dose | Drug | Linagliptin, low dose |
| Linagliptin, medium dose | Drug | Linagliptin, medium dose |
| Linagliptin, high dose | Drug | Linagliptin, high dose |
Primary outcome
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of linagliptin
Time frame: up to 168 hours after first drug administration at each visit
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of linagliptin
Time frame: up to 168 hours after first drug administration at each visit
Cτ,ss (average measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of linagliptin
Time frame: up to 168 hours after first drug administration at each visit
4 secondary outcomes
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1750
Time frame: up to 168 hours after first drug administration at each visit
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1750
Time frame: up to 168 hours after first drug administration at each visit
Number of patients with adverse events
Time frame: up to 53 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: within 10 days after last study drug administration
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 8 Jul 2014.
- Related InfoLink 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Linagliptin, low dose, Linagliptin, medium dose and Linagliptin, high dose in people with Healthy, run by Boehringer Ingelheim.
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 20 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of linagliptin (time frame: up to 168 hours after first drug administration at each visit). The study lists 3 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 8 Jul 2014.