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The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 207127 NA (low dose) | Experimental | Single dose of BI 207127 NA |
|
| Matching placebo (low dose) | Placebo Comparator | Single dose of matching placebo |
|
| BI 207127 NA (medium dose) | Experimental | Single dose of BI 207127 NA |
|
| Matching placebo (medium dose) | Placebo Comparator | Single dose of matching placebo |
|
| BI 207127 NA (high dose) | Experimental | Single dose of BI 207127 NA |
|
| Matching placebo (high dose) | Placebo Comparator | Single dose of matching placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Matching placebo (low dose) | Drug | single dose of matching placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Drug Related Adverse Events | Number of subjects with investigator-defined drug-related adverse events (AEs). Tolerability assessment endpoint. The investigator assessed the possible causal relationship between all AEs and the investigational drug, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, and confounding factors such as concomitant medication, concomitant diseases, and relevant history. | From first administration of study drug (drug related AEs) until 14 days after end of trial visit, upto 17 days. |
| Number of Subjects With Adverse Events as Determined by Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG | Clinical relevant abnormalities for vital signs, blood chemistry, haematology, urinanalysis and ECG. Tolerability assessment endpoint. New abnormal findings or worsening of baseline conditions were reported as adverse events. Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure). | From signing the informed consent (within 21 days before drug administration) until 14 days after end of trial visit, upto 38 days. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ of Deleobuvir | Area under the concentration-time curve of the analyte in plasma (Deleobuvir) over the time interval from 0 extrapolated to infinity (AUC0-∞). | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h (hours) after drug administration |
| Tmax of Deleobuvir |
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1241.8.8201 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
The decision to proceed to the next higher dose group was based upon the safety of the preceding dose group. Caucasian subjects were randomised to receive either placebo or 1200 mg BI 207127 NA; this dose group could be started independently from the results of dose escalation in the Asian subjects.
60 subjects were included (27 Chinese, 25 Japanese, and 8 Caucasian subjects). 24 Japanese and 24 Chinese subjects were randomised to 1 of 3 (rising) dose groups and received single oral doses of either 400mg, 800mg, or 1200mg of BI 207127 NA or of the respective placebo. Caucasian subjects were randomised to 1200 mg BI 207127 NA or placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Caucasian Subjects) | Caucasian subjects who received matching placebo. Oral with 240 mL of water in fed condition. |
| FG001 | 1200 mg Deleobuvir (Caucasian Subjects) | Caucasian subjects who received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| BI 207127 NA (medium dose) |
| Drug |
Single does of BI 207127 NA |
|
| BI 207127 NA (low dose) | Drug | single dose of BI 207127 NA |
|
| Matching placebo (medium dose) | Drug | Single dose of matching placebo |
|
| BI 207127 NA (high dose) | Drug | Single dose of BI 207127 NA |
|
| Matching placebo (high dose) | Drug | Single dose of matching placebo |
|
Time from dosing to the maximum measured concentration of the analyte in plasma (Deleobuvir). |
| -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| Cmax of Deleobuvir | Maximum measured concentration of the analyte in plasma (Deleobuvir). | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| AUC0-∞ of BI 208333 (Metabolite of Deleobuvir) | Area under the concentration-time curve of the analyte in plasma (BI 208333) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms "Japanese 400mg", "Japanese 800mg" and "Chinese 400mg" cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞. | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| Tmax of BI 208333 (Metabolite of Deleobuvir) | Time from dosing to the maximum measured concentration of the analyte in plasma (BI 208333) . | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| Cmax of BI 208333 (Metabolite of Deleobuvir) | Maximum measured concentration of the analyte in plasma (BI 208333). | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| AUC0-∞ of CD 6168 (Metabolite of Deleobuvir) | Area under the concentration-time curve of the analyte in plasma (CD 6168) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms "Japanese 1200mg" and "Chinese 400mg" cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞. | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| Tmax of CD 6168 (Metabolite of Deleobuvir) | Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168). | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| Cmax of CD 6168 (Metabolite of Deleobuvir) | Maximum measured concentration of the analyte in plasma (CD 6168). | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| AUC0-∞ of CD 6168 Acylglucuronide (Metabolite of Deleobuvir) | Area under the concentration-time curve of the analyte in plasma (CD 6168 Acylglucuronide) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms "Japanese 400mg", "Japanese 800mg", "Japanese 1200mg" and "Chinese 400mg" cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞. | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| Tmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir) | Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168 Acylglucuronide). The descriptive statistics of the arm "Chinese 400mg" cannot be determined due to limitation of available data above the "below limit of quantification (BLQ)". | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| Cmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir) | Maximum measured concentration of the analyte in plasma (CD 6168 Acylglucuronide). The descriptive statistics of the arm "Chinese 400mg" cannot be determined due to limitation of available data above the "below limit of quantification (BLQ)". | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| FG002 | Placebo (Japanese Subjects) | Japanese subjects who received matching placebo. Oral with 240 mL of water in fed condition. |
| FG003 | 400 mg Deleobuvir (Japanese Subjects) | Japanese subjects who received 400 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| FG004 | 800 mg Deleobuvir (Japanese Subjects) | Japanese subjects who received 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| FG005 | 1200mg Deleobuvir (Japanese Subjects) | Japanese subjects who received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| FG006 | Placebo (Chinese Subjects) | Chinese subjects who received matching placebo. Oral with 240 mL of water in fed condition. |
| FG007 | 400 mg Deleobuvir (Chinese Subjects) | Chinese subjects who received 400 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| FG008 | 800 mg Deleobuvir (Chinese Subjects) | Chinese subjects who received 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| FG009 | 1200 mg Deleobuvir (Chinese Subjects) | Chinese subjects who received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The treated set (full analysis set according to ICH-E9): all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1200 mg Deleobuvir (Caucasian Subjects) | Caucasian subjects who received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| BG001 | Placebo (Caucasian Subjects) | Caucasian subjects who received matching placebo. Oral with 240 mL of water in fed condition. |
| BG002 | 400 mg Deleobuvir (Japanese Subjects) | Japanese subjects who received 400 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| BG003 | 800 mg Deleobuvir (Japanese Subjects) | Japanese subjects who received 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| BG004 | 1200mg Deleobuvir (Japanese Subjects) | Japanese subjects who received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| BG005 | Placebo (Japanese Subjects) | Japanese subjects who received matching placebo. Oral with 240 mL of water in fed condition. |
| BG006 | 400 mg Deleobuvir (Chinese Subjects) | Chinese subjects who received 400 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| BG007 | 800 mg Deleobuvir (Chinese Subjects) | Chinese subjects who received 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| BG008 | 1200 mg Deleobuvir (Chinese Subjects) | Chinese subjects who received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| BG009 | Placebo (Chinese Subjects) | Chinese subjects who received matching placebo. Oral with 240 mL of water in fed condition. |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Drug Related Adverse Events | Number of subjects with investigator-defined drug-related adverse events (AEs). Tolerability assessment endpoint. The investigator assessed the possible causal relationship between all AEs and the investigational drug, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, and confounding factors such as concomitant medication, concomitant diseases, and relevant history. | Treated set (full analysis set according to the International Conference on Harmonization (ICH) E9 guideline): all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment. | Posted | Number | Participants | From first administration of study drug (drug related AEs) until 14 days after end of trial visit, upto 17 days. |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Adverse Events as Determined by Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG | Clinical relevant abnormalities for vital signs, blood chemistry, haematology, urinanalysis and ECG. Tolerability assessment endpoint. New abnormal findings or worsening of baseline conditions were reported as adverse events. Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure). | The treated set. | Posted | Number | participants | From signing the informed consent (within 21 days before drug administration) until 14 days after end of trial visit, upto 38 days. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC0-∞ of Deleobuvir | Area under the concentration-time curve of the analyte in plasma (Deleobuvir) over the time interval from 0 extrapolated to infinity (AUC0-∞). | The pharmacokinetic (PK) analysis set: all evaluable subjects of the treated set who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | µmol*h/L | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h (hours) after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tmax of Deleobuvir | Time from dosing to the maximum measured concentration of the analyte in plasma (Deleobuvir). | The PK analysis set. | Posted | Median | Full Range | h | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmax of Deleobuvir | Maximum measured concentration of the analyte in plasma (Deleobuvir). | The PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | µmol/L | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC0-∞ of BI 208333 (Metabolite of Deleobuvir) | Area under the concentration-time curve of the analyte in plasma (BI 208333) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms "Japanese 400mg", "Japanese 800mg" and "Chinese 400mg" cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞. | The PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | µmol*h/L | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tmax of BI 208333 (Metabolite of Deleobuvir) | Time from dosing to the maximum measured concentration of the analyte in plasma (BI 208333) . | The PK analysis set. | Posted | Median | Full Range | h | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmax of BI 208333 (Metabolite of Deleobuvir) | Maximum measured concentration of the analyte in plasma (BI 208333). | The PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | µmol/L | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC0-∞ of CD 6168 (Metabolite of Deleobuvir) | Area under the concentration-time curve of the analyte in plasma (CD 6168) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms "Japanese 1200mg" and "Chinese 400mg" cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞. | The PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | µmol*h/L | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tmax of CD 6168 (Metabolite of Deleobuvir) | Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168). | The PK analysis set. | Posted | Median | Full Range | h | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmax of CD 6168 (Metabolite of Deleobuvir) | Maximum measured concentration of the analyte in plasma (CD 6168). | The PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | µmol/L | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC0-∞ of CD 6168 Acylglucuronide (Metabolite of Deleobuvir) | Area under the concentration-time curve of the analyte in plasma (CD 6168 Acylglucuronide) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms "Japanese 400mg", "Japanese 800mg", "Japanese 1200mg" and "Chinese 400mg" cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞. | The PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | µmol*h/L | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir) | Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168 Acylglucuronide). The descriptive statistics of the arm "Chinese 400mg" cannot be determined due to limitation of available data above the "below limit of quantification (BLQ)". | The PK analysis set. | Posted | Median | Full Range | h | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir) | Maximum measured concentration of the analyte in plasma (CD 6168 Acylglucuronide). The descriptive statistics of the arm "Chinese 400mg" cannot be determined due to limitation of available data above the "below limit of quantification (BLQ)". | The PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | µmol/L | -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration |
|
Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | All (Caucasian, Japanese and Chinese) subjects that received matching placebo. Oral with 240 mL of water in fed condition. | 0 | 14 | 5 | 14 | ||
| EG001 | 400 mg Deleobuvir | All (Japanese and Chinese) subjects that received 400 mg Deleobuvir. Oral with 240 mL of water in fed condition. | 0 | 12 | 1 | 12 | ||
| EG002 | 800 mg Deleobuvir | All (Japanese and Chinese) subjects that received 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. | 0 | 12 | 2 | 12 | ||
| EG003 | 1200 mg Deleobuvir | All (Caucasian, Japanese and Chinese) subjects that received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. | 0 | 18 | 14 | 18 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Male |
|
| OG003 | 800 mg Deleobuvir (Japanese Subjects) | Japanese subjects who received 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG004 | 1200mg Deleobuvir (Japanese Subjects) | Japanese subjects who received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG005 | Placebo (Japanese Subjects) | Japanese subjects who received matching placebo. Oral with 240 mL of water in fed condition. |
| OG006 | 400 mg Deleobuvir (Chinese Subjects) | Chinese subjects who received 400 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG007 | 800 mg Deleobuvir (Chinese Subjects) | Chinese subjects who received 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG008 | 1200 mg Deleobuvir (Chinese Subjects) | Chinese subjects who received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG009 | Placebo (Chinese Subjects) | Chinese subjects who received matching placebo. Oral with 240 mL of water in fed condition. |
|
|
Japanese subjects who received a single dose of 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG004 | Chinese 400 mg | Chinese subjects who received a single dose of 400 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG005 | Chinese 800 mg | Chinese subjects who received a single dose of 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG006 | Chinese 1200 mg | Chinese subjects who received a single dose of 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
|
|
| OG004 |
| Chinese 400 mg |
Chinese subjects who received a single dose of 400 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG005 | Chinese 800 mg | Chinese subjects who received a single dose of 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG006 | Chinese 1200 mg | Chinese subjects who received a single dose of 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
|
|
| OG004 | Chinese 400 mg | Chinese subjects who received a single dose of 400 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG005 | Chinese 800 mg | Chinese subjects who received a single dose of 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG006 | Chinese 1200 mg | Chinese subjects who received a single dose of 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
|
|
| Chinese 1200 mg |
Chinese subjects who received a single dose of 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
|
|
| OG004 | Chinese 400 mg | Chinese subjects who received a single dose of 400 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG005 | Chinese 800 mg | Chinese subjects who received a single dose of 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG006 | Chinese 1200 mg | Chinese subjects who received a single dose of 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
|
|
| OG004 | Chinese 400 mg | Chinese subjects who received a single dose of 400 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG005 | Chinese 800 mg | Chinese subjects who received a single dose of 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG006 | Chinese 1200 mg | Chinese subjects who received a single dose of 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
|
|
| Chinese 800 mg |
Chinese subjects who received a single dose of 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG004 | Chinese 1200 mg | Chinese subjects who received a single dose of 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
|
|
| OG004 | Chinese 400 mg | Chinese subjects who received a single dose of 400 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG005 | Chinese 800 mg | Chinese subjects who received a single dose of 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG006 | Chinese 1200 mg | Chinese subjects who received a single dose of 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
|
|
| OG004 | Chinese 400 mg | Chinese subjects who received a single dose of 400 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG005 | Chinese 800 mg | Chinese subjects who received a single dose of 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG006 | Chinese 1200 mg | Chinese subjects who received a single dose of 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Japanese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
| OG004 | Chinese 800 mg | Chinese subjects who received a single dose of 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG005 | Chinese 1200 mg | Chinese subjects who received a single dose of 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
|
|
Japanese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
| OG004 | Chinese 800 mg | Chinese subjects who received a single dose of 800 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
| OG005 | Chinese 1200 mg | Chinese subjects who received a single dose of 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition. |
|
|