HealthyPhase 1NCT02254096
Safety, Pharmacokinetics and Pharmacodynamics of BIRT 1696 BS in Healthy Human Subjects
A Phase 1 study testing BIRT 1696 BS, Grapefruit juice (GFJ) and High fat meal (HFM) in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objectives are: 1. To assess safety, pharmacokinetics, and pharmacodynamics of BIRT 1696 BS in rising single doses. 2. To assess safety, pharmacokinetics, and pharmacodynamics of single dose of 100 mg BIRT 1696 BS after grapefruit juice. 3. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIRT 1696 BS, Grapefruit juice (GFJ) and High fat meal (HFM)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Jul 2002
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age ≥18 and ≤60 years
- Body Mass Index ≥18.5 and ≤29.9 kg/m2
Who cannot join
- Female subjects who are lactating or of child bearing potential as defined by surgically sterile or post menopausal (no periods for at least 12 months and elevated follicle stimulating hormone with low estradiol while on no estrogen supplementation unless surgically sterile). Females should use barrier contraception (e.g. condoms) prior to administration of study medication, during the study and at least one month after release from the study. Women must have had negative blood pregnancy tests
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Relevant history of orthostatic hypotension, fainting spells or blackouts
Show all 21Show fewer
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
- Use of any drugs, which might influence the results of the trial, (< 10 days prior to administration or during the trial)
- Participation in another trial with an investigational drug (< 2 months prior to administration or during trial)
- Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco < 5 days prior to administration of study drug or during trial
- Blood donation or loss > 400 mL, < 1 month prior to administration or during the trial
- Excessive physical activities < 5 days prior to administration of study drug or during trial
- Clinically relevant laboratory abnormalities
- Any ECG value outside of the reference range of clinical relevance including, but not limited to QRS interval > 110 ms or QTcB > 450 ms (males) or QTcB > 470 ms (females)
- Inability to comply with dietary regimen of study centre
- Inability to comply with the investigator's instructions
About this study
Official title: Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BIRT 1696 BS as a Solution (10, 100, 400, 1000, 2000, 3000 mg) in 15 ml PEG 400 to Healthy Human Subjects. A Three Part Study: Part 1 Placebo-controlled, Randomised, Dose Escalating Double Blinded Within Each Dose Level; Part 2 Open Label Grapefruit Juice Effect in 100 mg Dose Level Group; Part 3 Open Label Food Effect in 400 mg Dose Level Group
The objectives are:
- To assess safety, pharmacokinetics, and pharmacodynamics of BIRT 1696 BS in rising single doses.
- To assess safety, pharmacokinetics, and pharmacodynamics of single dose of 100 mg BIRT 1696 BS after grapefruit juice.
- To asses safety and pharmacokinetics of single dose of 400 mg BIRT 1696 BS after a 67 g fat and high caloric breakfast.
- Conditions
- Healthy
- Being tested
- BIRT 1696 BS, Placebo, Grapefruit juice (GFJ), High fat meal (HFM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIRT 1696 BSDrug
PlaceboDrug
Grapefruit juice (GFJ)Other
High fat meal (HFM)Other
| Study group | Role | What they receive |
|---|---|---|
| BIRT 1696 BS | Experimental | single escalating dose phase Receives: Drug: BIRT 1696 BS |
| BIRT 1696 BS + GFJ | Experimental | single dose grapefruit effect arm Receives: Drug: BIRT 1696 BS; Other: Grapefruit juice (GFJ) |
| BIRT 1696 BS + HFM | Experimental | single dose food effect arm Receives: Drug: BIRT 1696 BS; Other: High fat meal (HFM) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: up to 44 days
Number of subjects with clinically significant changes in vital signs
Measured: up to 44 days
Number of subjects with abnormal changes in laboratory parameters
Measured: up to 44 days
Number of subjects with abnormal findings in electrocardiogram
Measured: up to 44 days
Number of subjects with abnormal findings in physical examination
Measured: up to 44 days
Assessment of tolerability on a verbal rating scale
Measured: up to 44 days
Secondary outcomes (10)
Maximum observed plasma concentration (Cmax)
Measured: up to 48 hours after drug administration
Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞)
Measured: up to 48 hours after drug administration
Time to the maximum plasma concentration (tmax)
Measured: up to 48 hours after drug administration
Elimination half-life (t1/2)
Measured: up to 48 hours after drug administration
Total apparent oral clearance of drug from plasma after oral administration (CL/F)
Measured: up to 48 hours after drug administration
Apparent volume of distribution based on terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
Measured: up to 48 hours after drug administration
Mean residence time (MRT)
Measured: up to 48 hours after drug administration
Urinary excretion
Measured: up to 24 hours after drug administration
Receptor occupancy as determined by binding of anti-lymphocyte function associated antigen-1 antibody fragment (Fab)
Measured: up to 168 hours after drug administration
Inhibition of superantigen induced interleukin-2 production ex vivo
Measured: up to 168 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startMay 2002
- Primary completionJul 2002
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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 46 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
- NCT02254096
- Sponsor's protocol ID
- 1195.1
- Status last verified
- Sep 2014
- First submitted
- 30 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BIRT 1696 BS as a Solution (10, 100, 400, 1000, 2000, 3000 mg) in 15 ml PEG 400 to Healthy Human Subjects. A Three Part Study: Part 1 Placebo-controlled, Randomised, Dose Escalating Double Blinded Within Each Dose Level; Part 2 Open Label Grapefruit Juice Effect in 100 mg Dose Level Group; Part 3 Open Label Food Effect in 400 mg Dose Level Group
- ClinicalTrials.gov ID
- NCT02254096
- Acronym / sponsor ID
- 1195.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Jul 2002 (actual)
- First posted
- 1 Oct 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.
The objectives are:
- To assess safety, pharmacokinetics, and pharmacodynamics of BIRT 1696 BS in rising single doses.
- To assess safety, pharmacokinetics, and pharmacodynamics of single dose of 100 mg BIRT 1696 BS after grapefruit juice.
- To asses safety and pharmacokinetics of single dose of 400 mg BIRT 1696 BS after a 67 g fat and high caloric breakfast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIRT 1696 BS | Experimental | Drug: BIRT 1696 BSsingle escalating dose phase |
| BIRT 1696 BS + GFJ | Experimental | Drug: BIRT 1696 BS, Other: Grapefruit juice (GFJ)single dose grapefruit effect arm |
| BIRT 1696 BS + HFM | Experimental | Drug: BIRT 1696 BS, Other: High fat meal (HFM)single dose food effect arm |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age ≥18 and ≤60 years
- Body Mass Index ≥18.5 and ≤29.9 kg/m2
Key exclusion criteria (21 listed)
- Female subjects who are lactating or of child bearing potential as defined by surgically sterile or post menopausal (no periods for at least 12 months and elevated follicle stimulating hormone with low estradiol while on no estrogen supplementation unless surgically sterile). Females should use barrier contraception (e.g. condoms) prior to administration of study medication, during the study and at least one month after release from the study. Women must have had negative blood pregnancy tests
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of 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 |
|---|---|---|
| BIRT 1696 BS | Drug | BIRT 1696 BS, BIRT 1696 BS + GFJ, BIRT 1696 BS + HFM |
| Placebo | Drug | Placebo |
| Grapefruit juice (GFJ) | Other | BIRT 1696 BS + GFJ |
| High fat meal (HFM) | Other | BIRT 1696 BS + HFM |
Primary outcome
Number of subjects with adverse events
Time frame: up to 44 days
Number of subjects with clinically significant changes in vital signs
Time frame: up to 44 days
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 44 days
Number of subjects with abnormal findings in electrocardiogram
Time frame: up to 44 days
Number of subjects with abnormal findings in physical examination
Time frame: up to 44 days
Assessment of tolerability on a verbal rating scale
Time frame: up to 44 days
10 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: up to 48 hours after drug administration
Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞)
Time frame: up to 48 hours after drug administration
Time to the maximum plasma concentration (tmax)
Time frame: up to 48 hours after drug administration
Elimination half-life (t1/2)
Time frame: up to 48 hours after drug administration
Total apparent oral clearance of drug from plasma after oral administration (CL/F)
Time frame: up to 48 hours after drug administration
Apparent volume of distribution based on terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
Time frame: up to 48 hours after drug administration
Mean residence time (MRT)
Time frame: up to 48 hours after drug administration
Urinary excretion
Time frame: up to 24 hours after drug administration
Receptor occupancy as determined by binding of anti-lymphocyte function associated antigen-1 antibody fragment (Fab)
Time frame: up to 168 hours after drug administration
Inhibition of superantigen induced interleukin-2 production ex vivo
Time frame: up to 168 hours after 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 1 Oct 2014.
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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 BIRT 1696 BS, Grapefruit juice (GFJ) and High fat meal (HFM) 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 21 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 1 Oct 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. Some participants in this study may receive a placebo. 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?
Number of subjects with adverse events (time frame: up to 44 days). The study lists 6 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 1 Oct 2014.