Phase 1
Completed N=193
Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT01505491 ↗
Enrolled (actual)
193
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) — 2740; 2390; 2050 Micro-gram*hour/milliliter (μg*h/mL) — p=0.1163
Summary
This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to establish pharmacokinetic equivalence of BI 695501 to adalimumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
2740; 2390; 2050 | 0.1163 |
| PRIMARY Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) |
2480; 2250; 1890 | 0.0303 sig |
| PRIMARY Maximum Measured Concentration of the BI 695501 in Plasma (Cmax) |
4.47; 4.07; 3.74 | 0.0212 sig |
| SECONDARY Terminal Half- Life of the BI 695501 in Plasma (t1/2) |
292; 230; 236 | — |
| SECONDARY Apparent Clearance of the BI 695501 in the Plasma After Extra-vascular Administration (CL/F) |
0.244; 0.279; 0.326 | — |
Eligibility Criteria
Inclusion criteria
- Healthy males
- Body mass index (BMI) =18.5 to =29.9 kg/m2
Exclusion criteria
- Any clinically relevant abnormal finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant previous or concomitant disease as judged by the investigator.
- Chronic or relevant acute infections. A negative result for Human Immunodeficiency Virus, Hepatitis B and Hepatitis C testing is required for participation.
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of prescribed or over-the-counter drugs with a long half-life (>24 hours) within at least one month or less than 5 half-lives of the respective drug prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking during days of confinement at the study center
- Alcohol abuse (average more than 30 g/day)
- Current drug abuse
Data sourced from ClinicalTrials.gov (NCT01505491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.