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To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1467335 Following Multiple Dose Administration Over 28 Days
Phase 1 trial testing BI 1467335 in Healthy in 36 participants. Completed in 12 July 2017.
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 7 July 2016 |
| Primary completion | 12 July 2017 |
| Estimated completion | 12 July 2017 |
| Sites | 1 location across Germany |
Boehringer Ingelheim — full company profile →
Adults 18 to 50, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of subjects with investigator defined drug-related adverse events (AEs) is reported.
| Group | Value | 95% CI |
|---|---|---|
| BI 1467335 10 mg (Low Dose) | 3 | |
| BI 1467335 15 mg (Medium Dose) | 4 | |
| BI 1467335 20 mg (High Dose) | 6 | |
| Placebo | 4 |
Cmax is the maximum measured concentration of BI 1467335 in plasma after administration of the first dose.
| Group | Value | 95% CI |
|---|---|---|
| BI 1467335 10 mg (Low Dose) | 1.79 | ± 45.9 |
| BI 1467335 15 mg (Medium Dose) | 9.74 | ± 30.6 |
| BI 1467335 20 mg (High Dose) | 25.0 | ± 59.5 |
AUC0-24 is the area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose.
| Group | Value | 95% CI |
|---|---|---|
| BI 1467335 10 mg (Low Dose) | 2.34 | ± 61.2 |
| BI 1467335 15 mg (Medium Dose) | 17.0 | ± 40.6 |
| BI 1467335 20 mg (High Dose) | 41.6 | ± 39.7 |
Cmax,28 is the maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose.
| Group | Value | 95% CI |
|---|---|---|
| BI 1467335 10 mg (Low Dose) | 72.1 | ± 71.0 |
| BI 1467335 15 mg (Medium Dose) | 189 | ± 15.3 |
| BI 1467335 20 mg (High Dose) | 255 | ± 24.6 |
AUC0-24,28 is the area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the 28th dose.
| Group | Value | 95% CI |
|---|---|---|
| BI 1467335 10 mg (Low Dose) | 373 | ± 143 |
| BI 1467335 15 mg (Medium Dose) | 1720 | ± 12.8 |
| BI 1467335 20 mg (High Dose) | 2940 | ± 29.5 |
Time frame: From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | BI 1467335 10 mg (Low Dose) | BI 1467335 15 mg (Medium D… | BI 1467335 20 mg (High Dose) |
|---|---|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Flatulence | Gastrointestinal disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Ear discomfort | Ear and labyrinth disorders | — | — | — | — |
| Eyelid oedema | Eye disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — |
| Aphthous ulcer | Gastrointestinal disorders | — | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — |
| Toothache | Gastrointestinal disorders | — | — | — | — |
| Vessel puncture site haematoma | General disorders | — | — | — | — |
| Vessel puncture site pain | General disorders | — | — | — | — |
| Oral herpes | Infections and infestations | — | — | — | — |
| Rhinitis | Infections and infestations | — | — | — | — |
| Arthropod bite | Injury, poisoning and procedural complications | — | — | — | — |
| Facial bones fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Groin pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Muscle twitching | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Spinal pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Dysgeusia | Nervous system disorders | — | — | — | — |
| Paraesthesia | Nervous system disorders | — | — | — | — |
| Apathy | Psychiatric disorders | — | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
Data from ClinicalTrials.gov NCT02733627 adverse events section.
The primary objective of this trial is to investigate the safety and tolerability of BI 1467335 in healthy male and female subjects following oral administration of multiple rising doses over 28 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and target engagement biomarkers of BI 1467335 after multiple dosing.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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