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

NCT02217631 | Completed Phase 1

• 1 other identifier: 1262.2
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of patients with adverse events

  up to day 14

• Number of patients with clinically significant findings in vital signs

  blood pressure, pulse rate, body temperature, orthostatic test

  up to 10 days after last drug administration

• Number of patients with clinically significant findings in ECG

  up to 10 days after last drug administration

• Number of patients with clinically significant findings in laboratory tests

  up to 10 days after last drug administration

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

  up to 10 days after last drug administration

Secondary Outcomes (26)

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

  up to day 13

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

  up to day 13

• 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)

  up to day 13

• 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-∞)

  up to day 13

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

  up to day 13

Study Arms (4)

BI 653048 BS H3PO4

EXPERIMENTAL

dose escalation

Drug: BI 653048 BS H3PO4

Prednisolone low dose

ACTIVE COMPARATOR

Drug: Prednisolone low dose

Prednisolone high dose

ACTIVE COMPARATOR

Drug: Prednisolone high dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 653048 BS H3PO4 DRUG

BI 653048 BS H3PO4

Prednisolone low dose DRUG

Prednisolone low dose

Prednisolone high dose DRUG

Prednisolone high dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Related Publications (1)

• 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.

  PMID: 30908082 DERIVED

MeSH Terms

Interventions

BI 653048 BS H3PO4; Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 15, 2014
• Study Start: October 1, 2009
• Primary Completion: March 1, 2010
• Last Updated: August 15, 2014

Record last verified: 2014-08