HealthyPhase 1NCT02217644
Safety, Tolerability and Pharmacokinetics of BI 653048 H3PO4 Oral Drinking Solution in Healthy Male Volunteers
A Phase 1 study testing BI 653048 H3PO4 solution, BI 653048 H3PO4 low dose capsule and BI 653048 H3PO4 high dose capsule in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Investigation of safety and tolerability of BI 653048 H3PO4 following the administration of single rising doses of an aqueous solution in healthy male subjects Pharmacokinetic and pharmacodynamic characteristics of BI 653048, including the investigation of dose proportionality Investigation of relative bioavailability… Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 653048 H3PO4 solution, BI 653048 H3PO4 low dose capsule and BI 653048 H3PO4 high dose capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Jun 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males 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 electrocardiogram (ECG), clinical laboratory tests
- Age ≥21 years and ≤50 years
- Body Mass Index (BMI) ≥18.5 kg/m2 and BMI ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the trial in accordance with Good Clinical Practice (GCP) 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
- 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 22Show fewer
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (>24 h) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
- Excessive physical activities (within 1 week prior to administration or during the trial)
- Any laboratory value outside the reference range that was of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for Torsades des Pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
- Not willing to use adequate contraception (condom use plus another form of contraception e.g., spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole trial period from the time of the first intake of trial drug until 3 months after the last intake
About this study
Official title: Safety, Tolerability and Pharmacokinetics of BI 653048 H3PO4 Oral Drinking Solution in Healthy Male Volunteers (Dose Range: 0.1 mg - 1500 mg). A Singleblind (Within Dose Groups), Randomised, Placebo-controlled Within Dose Groups, Single Rising Dose Phase I Study
- Investigation of safety and tolerability of BI 653048 H3PO4 following the administration of single rising doses of an aqueous solution in healthy male subjects
- Pharmacokinetic and pharmacodynamic characteristics of BI 653048, including the investigation of dose proportionality
- Investigation of relative bioavailability of capsules versus aqueous solution
- Conditions
- Healthy
- Being tested
- BI 653048 H3PO4 solution, BI 653048 H3PO4 low dose capsule, BI 653048 H3PO4 high dose capsule, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 653048 H3PO4 solutionDrug
BI 653048 H3PO4 low dose capsuleDrug
BI 653048 H3PO4 high dose capsuleDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 653048 H3PO4 solution | Experimental | single rising doses Receives: Drug: BI 653048 H3PO4 solution |
| BI 653048 H3PO4 low dose capsule | Experimental | Not described Receives: Drug: BI 653048 H3PO4 low dose capsule |
| BI 653048 H3PO4 high dose capsule | Experimental | Not described Receives: Drug: BI 653048 H3PO4 high dose capsule |
| 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 patients with clinically significant findings in vital signs
blood pressure (BP), pulse rate (PR) respiratory rate (RR), oral body temperature (T), orthostatic test
Measured: up to 10 days after drug administration
Number of patients with clinically significant findings in ECG
Measured: up to 10 days after drug administration
Number of patients with clinically significant findings in laboratory tests
Measured: up to 10 days after drug administration
Number of patients with adverse events
Measured: up to 10 days after drug administration
Assessment of tolerability performed by the investigator on a four-point scale
Measured: up to 10 days after drug administration
Secondary outcomes (24)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 72 hours after drug administration
tmax (time from dosing to maximum measured concentration)
Measured: up to 72 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 72 hours after drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Measured: up to 72 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 72 hours after drug administration
AUCt1-t2 (Area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)
Measured: up to 72 hours after drug administration
λz (terminal rate constant in plasma)
Measured: up to 72 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 72 hours after drug administration
MRTp.o. (mean residence time of the analyte in the body after oral administration)
Measured: up to 72 hours after drug administration
CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
Measured: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 72 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Measured: up to 48 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: up to 48 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: up to 48 hours after drug administration
Dose-normalised Cmax
Measured: up to 72 hours after drug administration
Dose-normalized AUC0-∞
Measured: up to 72 hours after drug administration
Emax (maximum measured concentration of the biomarker in blood or serum)
Measured: up to 72 hours after drug administration
Emin (minimum measured concentration of the biomarker in blood or serum)
Measured: up to 72 hours after drug administration
Tmin (time from dosing to minimum measured concentration of the biomarker)
Measured: up to 72 hours after drug administration
Tmax (time from dosing to maximum measured concentration of the biomarker)
Measured: up to 72 hours after drug administration
AUECt1-t2 (area under the concentration-time curve of the biomarker in the blood over the time interval from t1 to t2)
Measured: up to 72 hours after drug administration
AUECbelow_base (area under the baseline corrected concentration-time curve of the biomarker)
Measured: up to 72 hours after drug administration
AUECabove_base (area above the baseline corrected concentration-time curve of the biomarker)
Measured: up to 72 hours after drug administration
Expression of glucocorticoid responsive genes
Measured: up to 72 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 posted15 Aug 2014 (estimated)
- Study startNov 2008
- Primary completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 80 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
- NCT02217644
- Sponsor's protocol ID
- 1262.1
- Status last verified
- Aug 2014
- First submitted
- 14 Aug 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
Publications
Harcken C, Scholl P, Nabozny G, Thomson D, Bianchi D. Clinical profile of the functionally selective glucocorticoid receptor agonist BI 653048 in healthy male subjects. Expert Opin Investig Drugs. 2019 May;28(5):489-496. doi: 10.1080/13543784.2019.1599859. Epub 2019 Apr 9.
PubMed 30908082
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of BI 653048 H3PO4 Oral Drinking Solution in Healthy Male Volunteers (Dose Range: 0.1 mg - 1500 mg). A Singleblind (Within Dose Groups), Randomised, Placebo-controlled Within Dose Groups, Single Rising Dose Phase I Study
- ClinicalTrials.gov ID
- NCT02217644
- Acronym / sponsor ID
- 1262.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (actual)
- First posted
- 15 Aug 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.
- Investigation of safety and tolerability of BI 653048 H3PO4 following the administration of single rising doses of an aqueous solution in healthy male subjects
- Pharmacokinetic and pharmacodynamic characteristics of BI 653048, including the investigation of dose proportionality
- Investigation of relative bioavailability of capsules versus aqueous solution
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BI 653048 H3PO4 solution | Experimental | Drug: BI 653048 H3PO4 solutionsingle rising doses |
| BI 653048 H3PO4 low dose capsule | Experimental | Drug: BI 653048 H3PO4 low dose capsule |
| BI 653048 H3PO4 high dose capsule | Experimental | Drug: BI 653048 H3PO4 high dose capsule |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males 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 electrocardiogram (ECG), clinical laboratory tests
- Age ≥21 years and ≤50 years
- Body Mass Index (BMI) ≥18.5 kg/m2 and BMI ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the trial in accordance with Good Clinical Practice (GCP) and the local legislation
Key exclusion criteria (22 listed)
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- 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 |
|---|---|---|
| BI 653048 H3PO4 solution | Drug | BI 653048 H3PO4 solution |
| BI 653048 H3PO4 low dose capsule | Drug | BI 653048 H3PO4 low dose capsule |
| BI 653048 H3PO4 high dose capsule | Drug | BI 653048 H3PO4 high dose capsule |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with clinically significant findings in vital signs
Time frame: up to 10 days after drug administration
blood pressure (BP), pulse rate (PR) respiratory rate (RR), oral body temperature (T), orthostatic test
Number of patients with clinically significant findings in ECG
Time frame: up to 10 days after drug administration
Number of patients with clinically significant findings in laboratory tests
Time frame: up to 10 days after drug administration
Number of patients with adverse events
Time frame: up to 10 days after drug administration
Assessment of tolerability performed by the investigator on a four-point scale
Time frame: up to 10 days after drug administration
24 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
tmax (time from dosing to maximum measured concentration)
Time frame: up to 72 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 72 hours after drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: up to 72 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 72 hours after drug administration
AUCt1-t2 (Area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)
Time frame: up to 72 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 72 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 72 hours after drug administration
MRTp.o. (mean residence time of the analyte in the body after oral administration)
Time frame: up to 72 hours after drug administration
CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
Time frame: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: up to 48 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: up to 48 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: up to 48 hours after drug administration
Dose-normalised Cmax
Time frame: up to 72 hours after drug administration
Dose-normalized AUC0-∞
Time frame: up to 72 hours after drug administration
Emax (maximum measured concentration of the biomarker in blood or serum)
Time frame: up to 72 hours after drug administration
Emin (minimum measured concentration of the biomarker in blood or serum)
Time frame: up to 72 hours after drug administration
Tmin (time from dosing to minimum measured concentration of the biomarker)
Time frame: up to 72 hours after drug administration
Tmax (time from dosing to maximum measured concentration of the biomarker)
Time frame: up to 72 hours after drug administration
AUECt1-t2 (area under the concentration-time curve of the biomarker in the blood over the time interval from t1 to t2)
Time frame: up to 72 hours after drug administration
AUECbelow_base (area under the baseline corrected concentration-time curve of the biomarker)
Time frame: up to 72 hours after drug administration
AUECabove_base (area above the baseline corrected concentration-time curve of the biomarker)
Time frame: up to 72 hours after drug administration
Expression of glucocorticoid responsive genes
Time frame: up to 72 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 15 Aug 2014.
- Derived from this study: PubMed 30908082Harcken C, Scholl P, Nabozny G, Thomson D, Bianchi D. Clinical profile of the functionally selective glucocorticoid receptor agonist BI 653048 in healthy male subjects. Expert Opin Investig Drugs. 2019 May;28(5):489-496. doi: 10.1080/13543784.2019.1599859. Epub 2019 Apr 9.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 BI 653048 H3PO4 solution, BI 653048 H3PO4 low dose capsule and BI 653048 H3PO4 high dose capsule 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 22 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 15 Aug 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 patients with clinically significant findings in vital signs (time frame: up to 10 days after drug administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02217644, which also lists 1 linked publication.
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 15 Aug 2014.