HealthyPhase 1NCT02202512
Effect of Repeated Doses of BI 1060469 and BI 1021958 on Glomerular Filtration Rate (GFR) in Healthy Volunteers
A Phase 1 study testing Cimetidine, BI 1060469 high dose and BI 1060469 low dose in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
Main objective is to investigate the measured glomerular filtration rate (mGFR) as assessed by iohexol clearance in healthy male normovolemic subjects after oral administration of single and repeated doses of BI 1060469, and BI 1021958. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cimetidine, BI 1060469 high dose and BI 1060469 low dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Dec 2014
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects according to the investigators assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests, including negative test result on occult blood in stool (only for subjects assigned to Naproxen)
- Age 18 to 45 years (incl.)
- Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation
Who cannot join
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
- Repeated measurement of systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, or pulse rate outside the range of 50 to 90 mmHg
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Serum creatinine laboratory value out of the normal range
- GFR (Glomerular Filtration Rate) < 90 mL/ min at screening
- Urinary toral protein/creatinine ratio > 0,1 mg protein/ mg creatinine
- Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
- Further exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Repeated Oral Doses of BI 1060469, BI 1021958 and Active Controls, Cimetidine and Naproxen, on Measured GFR Via Renal Clearance of Iohexol in Healthy Male Subjects (a Phase I Study; Single-blind, Randomized, Placebo-controlled Within BI Groups and Open-label for the Active Controls)
Main objective is to investigate the measured glomerular filtration rate (mGFR) as assessed by iohexol clearance in healthy male normovolemic subjects after oral administration of single and repeated doses of BI 1060469, and BI 1021958.
The secondary objective of this trial is to investigate the glomerular filtration rate (GFR) as assessed by 24 hours creatinine clearance in healthy male normovolemic subjects after oral administration of single and repeated doses of BI 1060469, and BI 1021958.
- Conditions
- Healthy
- Being tested
- Placebo, Cimetidine, BI 1060469 high dose, BI 1060469 low dose, Naproxen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
tablets
CimetidineDrug
PlaceboDrug
tablets
PlaceboDrug
tablets
BI 1060469 high doseDrug
tablets
BI 1060469 low doseDrug
tablets
NaproxenDrug
BI 1021958Drug
tablets
| Study group | Role | What they receive |
|---|---|---|
| BI 1060469 low dose | Experimental | Low-Dose,Tablet,oral administration with 240 ml water,over 10 days Receives: Drug: Placebo; Drug: BI 1060469 low dose |
| BI 1060469 high dose | Experimental | High-Dose,Tablets,oral administration with 240 ml water, over 10 days Receives: Drug: Placebo; Drug: BI 1060469 high dose |
| Cimetidine | Active comparator | Not described Receives: Drug: Cimetidine |
| Naproxen | Active comparator | Not described Receives: Drug: Naproxen |
| BI 1021958 | Experimental | High-Dose,Tablets,oral administration with 240 ml water, over 10 days Receives: Drug: Placebo; Drug: BI 1021958 |
What is being measured
The primary outcome is the main question the study is designed to answer.
measured glomerular filtration rate (mGFR) based on renal iohexol clearance
Measured: up to day 11
Secondary outcomes (1)
measured urinary 24-hour creatinine clearance
Measured: up to day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
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
- Single blind
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202512
- Sponsor's protocol ID
- 1333.43
- Other IDs
- 2014-000320-20, 2014
- Status last verified
- Dec 2014
- First submitted
- 28 Jul 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeated Oral Doses of BI 1060469, BI 1021958 and Active Controls, Cimetidine and Naproxen, on Measured GFR Via Renal Clearance of Iohexol in Healthy Male Subjects (a Phase I Study; Single-blind, Randomized, Placebo-controlled Within BI Groups and Open-label for the Active Controls)
- ClinicalTrials.gov ID
- NCT02202512
- Acronym / sponsor ID
- 1333.43
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 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.
Main objective is to investigate the measured glomerular filtration rate (mGFR) as assessed by iohexol clearance in healthy male normovolemic subjects after oral administration of single and repeated doses of BI 1060469, and BI 1021958.
The secondary objective of this trial is to investigate the glomerular filtration rate (GFR) as assessed by 24 hours creatinine clearance in healthy male normovolemic subjects after oral administration of single and repeated doses of BI 1060469, and BI 1021958.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BI 1060469 low dose | Experimental | Drug: Placebo, Drug: BI 1060469 low doseLow-Dose,Tablet,oral administration with 240 ml water,over 10 days |
| BI 1060469 high dose | Experimental | Drug: Placebo, Drug: BI 1060469 high doseHigh-Dose,Tablets,oral administration with 240 ml water, over 10 days |
| Cimetidine | Active comparator | Drug: Cimetidine |
| Naproxen | Active comparator | Drug: Naproxen |
| BI 1021958 | Experimental | Drug: Placebo, Drug: BI 1021958High-Dose,Tablets,oral administration with 240 ml water, over 10 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects according to the investigators assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests, including negative test result on occult blood in stool (only for subjects assigned to Naproxen)
- Age 18 to 45 years (incl.)
- Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation
Key exclusion criteria (8 listed)
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
- Repeated measurement of systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, or pulse rate outside the range of 50 to 90 mmHg
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Serum creatinine laboratory value out of the normal range
- GFR (Glomerular Filtration Rate) < 90 mL/ min at screening
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 |
|---|---|---|
| Placebotablets | Drug | BI 1060469 low dose |
| Cimetidine | Drug | Cimetidine |
| Placebotablets | Drug | BI 1060469 high dose |
| Placebotablets | Drug | BI 1021958 |
| BI 1060469 high dosetablets | Drug | BI 1060469 high dose |
| BI 1060469 low dosetablets | Drug | BI 1060469 low dose |
| Naproxen | Drug | Naproxen |
| BI 1021958tablets | Drug | BI 1021958 |
Primary outcome
measured glomerular filtration rate (mGFR) based on renal iohexol clearance
Time frame: up to day 11
1 secondary outcome
measured urinary 24-hour creatinine clearance
Time frame: up to day 11
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 24 Dec 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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
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 Cimetidine, BI 1060469 high dose and BI 1060469 low dose in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
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 8 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 24 Dec 2014. 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 Germany. 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?
measured glomerular filtration rate (mGFR) based on renal iohexol clearance (time frame: up to day 11). 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 24 Dec 2014.