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Single Rising Doses of BI 655064 in Healthy Chinese and Japanese Male Volunteers
Phase 1 trial testing Placebo in Healthy in 64 participants. Completed in 14 May 2014.
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 5 August 2013 |
| Primary completion | 14 May 2014 |
| Estimated completion | 14 May 2014 |
| Sites | 2 locations across Japan, South Korea |
Boehringer Ingelheim — full company profile →
Adults 20 to 45, male only, 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 participants with investigator defined drug-related adverse events (AEs) is reported.
| Group | Value | 95% CI |
|---|---|---|
| BI 655064 Dose Group 1 - 80 mg | 2 | |
| BI 655064 Dose Group 2 - 120 mg | 1 | |
| BI 655064 Dose Group 3 - 180 mg | 4 | |
| BI 655064 Dose Group 4 - 240 mg | 2 | |
| Placebo Matching BI 655064 | 1 |
Maximum measured concentration of BI 655064 in plasma (Cmax) is reported.
| Group | Value | 95% CI |
|---|---|---|
| BI 655064 Dose Group 1 - 80 mg | 888 | ± 501 |
| BI 655064 Dose Group 2 - 120 mg | 5160 | ± 51.6 |
| BI 655064 Dose Group 3 - 180 mg | 8650 | ± 41.1 |
| BI 655064 Dose Group 4 - 240 mg | 15700 | ± 54.2 |
| Group | Value | 95% CI |
|---|---|---|
| BI 655064 Dose Group 1 - 80 mg | 1550 | ± 315 |
| BI 655064 Dose Group 2 - 120 mg | 7210 | ± 92.8 |
| BI 655064 Dose Group 3 - 180 mg | 16300 | ± 73.6 |
| BI 655064 Dose Group 4 - 240 mg | 21300 | ± 53.4 |
Area under the concentration-time curve of the analyte BI 655064 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
| Group | Value | 95% CI |
|---|---|---|
| BI 655064 Dose Group 1 - 80 mg | 330 | ± 111 |
| BI 655064 Dose Group 2 - 120 mg | 1120 | ± 46.6 |
| BI 655064 Dose Group 3 - 180 mg | 2910 | ± 60.1 |
| BI 655064 Dose Group 4 - 240 mg | 5610 | ± 59.0 |
| Group | Value | 95% CI |
|---|---|---|
| BI 655064 Dose Group 1 - 80 mg | 464 | ± 74.1 |
| BI 655064 Dose Group 2 - 120 mg | 2020 | ± 78.8 |
| BI 655064 Dose Group 3 - 180 mg | 6430 | ± 83.3 |
| BI 655064 Dose Group 4 - 240 mg | 7780 | ± 57.1 |
Area under the concentration-time curve of the analyte BI 655064 in the plasma over the time interval from 0 to the last measurable time point (AUC0-tz) is reported.
| Group | Value | 95% CI |
|---|---|---|
| BI 655064 Dose Group 1 - 80 mg | 126 | ± 1740 |
| BI 655064 Dose Group 2 - 120 mg | 1110 | ± 47.2 |
| BI 655064 Dose Group 3 - 180 mg | 2900 | ± 60.4 |
| BI 655064 Dose Group 4 - 240 mg | 5680 | ± 52.4 |
| Group | Value | 95% CI |
|---|---|---|
| BI 655064 Dose Group 1 - 80 mg | 365 | ± 165 |
| BI 655064 Dose Group 2 - 120 mg | 2010 | ± 79.8 |
| BI 655064 Dose Group 3 - 180 mg | 6380 | ± 84.6 |
| BI 655064 Dose Group 4 - 240 mg | 7750 | ± 57.2 |
Time frame: From study drug administration until end-of-study examination, up to 77 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | BI 655064 Dose Group 1 - 8… | BI 655064 Dose Group 2 - 1… | BI 655064 Dose Group 3 - 1… | BI 655064 Dose Group 4 - 2… | Placebo Matching BI 655064 |
|---|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | — | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — |
| Tension headache | Nervous system disorders | — | — | — | — | — |
| Motion sickness | Ear and labyrinth disorders | — | — | — | — | — |
| Dry throat | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — |
| Gingival bleeding | Gastrointestinal disorders | — | — | — | — | — |
| Mouth ulceration | Gastrointestinal disorders | — | — | — | — | — |
| Acne | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Pain of skin | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Rash erythematous | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Skin exfoliation | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Tendonitis | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Administration site rash | General disorders | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — |
| Feeling cold | General disorders | — | — | — | — | — |
| Feeling hot | General disorders | — | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — | — | — | — |
| Muscle strain | Injury, poisoning and procedural complications | — | — | — | — | — |
Data from ClinicalTrials.gov NCT01917916 adverse events section.
Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising doses in healthy Asian male volunteers.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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