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HealthyPhase 1NCT02217631

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 653048 BS H3PO4 Capsule Multiple Rising Doses in Healthy Male Volunteers

A Phase 1 study testing BI 653048 BS H3PO4, Prednisolone low dose and Prednisolone high dose in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objectives of the trial were to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BI 653048 BS H3PO4 compared with prednisolone. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BI 653048 BS H3PO4, Prednisolone low dose and Prednisolone high dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
No sites listed yet
Study dates
Oct 2009to Mar 2010
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 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male subjects based on a complete medical history, physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, and clinical laboratory tests
  • Age of 18 to 50 years
  • Body mass index (BMI) of 18.5 to 29.9 kg/m2
  • Signed and dated written informed consent in accordance with Good Clinical Practice and the local legislation

Who cannot join

  • Any clinically relevant deviation from normal in the medical examination including blood pressure, pulse rate, and ECG
  • 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), psychiatric disorders, or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells, or blackouts
Show all 21Show fewer
  • Chronic or relevant acute infections
  • History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
  • Intake of drugs with a long half-life (>24 h) within at least 1 month or less than 10 half-lives of the respective drug before first treatment with study drug or during trial
  • Use of drugs which might reasonably influence the results of the trial or which prolong the QT/QTc interval within 10 days before first treatment with study drug or during trial
  • Participation in another trial with an investigational drug within 30 days before first treatment with study drug or during trial
  • Smoker (more than 10 cigarettes, 3 cigars, or 3 pipes per day)
  • Inability to refrain from smoking beginning from 1 day before first treatment with study drug until discharge from the clinical unit
  • Alcohol abuse (more than 60 grams per day)
  • Drug abuse
  • Blood donation of more than 100 mL within 4 weeks before first treatment with study drug or during trial
  • Excessive physical activities within 1 week before first treatment with study drug or during trial
  • Any laboratory value outside the reference range and of clinical relevance
  • Inability to comply with dietary regimen of trial site
  • A marked baseline prolongation of the QT/QTc interval (e.g. QTc intervals that are repeatedly longer than 450 ms)
  • A history of additional risk factors for torsades de points (e.g. heart failure, hypokalaemia, or family history of Long QT syndrome

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Biomarkers) of BI 653048 BS H3PO4 Capsule Formulation Administered as Multiple Doses of 25 mg to 200 mg qd for 10 Days. A Randomised, Double-blind Within Dose Groups, Placebo-controlled, Multiple Rising Dose Trial With Open-label Active Comparator

The objectives of the trial were to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BI 653048 BS H3PO4 compared with prednisolone.

Conditions
Healthy
Being tested
BI 653048 BS H3PO4, Prednisolone low dose, Prednisolone high dose, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 653048 BS H3PO4Drug

  • Prednisolone low doseDrug

  • Prednisolone high doseDrug

  • PlaceboDrug

Study groups in NCT02217631
Study groupRoleWhat they receive
BI 653048 BS H3PO4Experimentaldose escalation
Receives: Drug: BI 653048 BS H3PO4
Prednisolone low doseActive comparatorNot described
Receives: Drug: Prednisolone low dose
Prednisolone high doseActive comparatorNot described
Receives: Drug: Prednisolone high dose
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with adverse events

    Measured: up to day 14

  2. Number of patients with clinically significant findings in vital signs

    blood pressure, pulse rate, body temperature, orthostatic test

    Measured: up to 10 days after last drug administration

  3. Number of patients with clinically significant findings in ECG

    Measured: up to 10 days after last drug administration

  4. Number of patients with clinically significant findings in laboratory tests

    Measured: up to 10 days after last drug administration

  5. Assessment of tolerability by the investigator on a four-point scale

    Measured: up to 10 days after last drug administration

Secondary outcomes (26)

  1. Maximum measured concentration of the analyte in plasma at different time points (Cmax)

    Measured: up to day 13

  2. time from dosing to maximum measured concentration of the analyte at different time points (tmax)

    Measured: up to day 13

  3. Area under the concentration-time curve of the analyte in the plasma over time interval from 0 to the last measurable time point of the dose at different time points (AUC0-tz)

    Measured: up to day 13

  4. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity at different time points (AUC0-∞)

    Measured: up to day 13

  5. Percentage of the AUC0-∞ that is obtained by extrapolation at different time points (%AUCtz-∞)

    Measured: up to day 13

  6. Terminal phase elimination rate constant at different time points (λz)

    Measured: up to day 13

  7. Mean residence time of the analyte in the body after oral administration at different time points (MRTpo)

    Measured: up to day 13

  8. Terminal phase elimination half life at different time points (t1/2)

    Measured: up to day 13

  9. Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/Fss)

    Measured: up to day 13

  10. Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/Fss)

    Measured: up to day 13

  11. Minimum plasma concentration at steady state (Cmin,ss)

    Measured: up to day 13

  12. Dose-normalized Cmax at steady state (Cmax/Dss)

    Measured: up to day 13

  13. Dose-normalised AUC0-∞ at steady state (AUC0-∞/Dss)

    Measured: up to day 13

  14. Accumulation index of the analyte when comparing AUCτ (RA,AUCτ)

    Measured: up to day 13

  15. Accumulation index of the analyte when comparing Cmax (RA,Cmax)

    Measured: up to day 13

  16. Linearity index (LI)

    Measured: up to day 13

  17. Amount of analyte excreted in urine unchanged from t1 to t2 interval at different time points (Aet1-t2)

    Measured: up to day 11

  18. Renal clearance of the unchanged analyte at different time points (CLr)

    Measured: up to day 11

  19. Area under the serum biomarker concentration-time curve after the Nth dose (AUECN)

    Measured: up to day 13

  20. Area under the baseline (before dose level) but above serum biomarker concentration-time curve after the Nth dose (AUECbelow_base)

    Measured: up to day 13

  21. Minimum measured serum concentration of the biomarkers after the Nth dose (Emin,N)

    Measured: up to day 13

  22. Maximum measured serum concentration of the biomarkers after the Nth dose (Emax,N)

    Measured: up to day 13

  23. Serum biomarker concentration after the (N-1)th dose but before the Nth dose (Epre,N)

    Measured: up to day 13

  24. Measured value of the biomarkers in biological matrix at the set time point after Nth dose (EN)

    Measured: up to day 13

  25. Oral glucose insulin sensitivity (OGIS) index

    Measured: up to day 13

  26. Homeostasis model assessment (HOMA) value

    Measured: up to day 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2014 (estimated)
  2. Study startOct 2009
  3. Primary completionMar 2010

Resources

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
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02217631
Sponsor's protocol ID
1262.2
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 653048 BS H3PO4, Prednisolone low dose and Prednisolone 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 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 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 adverse events (time frame: up to day 14). 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 NCT02217631, 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.

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