HealthyPhase 1NCT01347086
Single Rising Dose Study of BI 207127 NA in Healthy Male Asian Volunteers and Single Dose Study of BI 207127 NA in Healthy Male Caucasian Volunteers
A Phase 1 study testing BI 207127 NA (medium dose), BI 207127 NA (low dose) and BI 207127 NA (high dose) in people with Healthy, run by Boehringer Ingelheim at 1 site in South Korea.
Trial summary
The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 207127 NA (medium dose), BI 207127 NA (low dose) and BI 207127 NA (high dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Jun 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
- Chinese ethnicity or Japanese ethnicity or Caucasian
- Body Mass Index (BMI) = 18.5 and BMI =25 kg/m2 for Japanese and Chinese, BMI =18.5 and BMI = 29.9 kg/m2 for Caucasians
Who cannot join
- Any finding of the medical examination (including Blood pressure(BP), Pulse rate (PR) and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
Trial locations and contacts
1 site in 1 country.
South Korea1 site
1241.8.8201 Boehringer Ingelheim Investigational Site
Seoul
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (400mg, 800mg, 1200mg) of BI 207127 NA in Healthy Male Asian Volunteers and Single Oral Dose (1200 mg) of BI 207127 NA in Healthy Male Caucasian Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Group)
The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA.
- Conditions
- Healthy
- Being tested
- Matching placebo (low dose), BI 207127 NA (medium dose), BI 207127 NA (low dose), Matching placebo (medium dose), BI 207127 NA (high dose)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matching placebo (low dose)Drug
single dose of matching placebo
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
| Study group | Role | What they receive |
|---|---|---|
| BI 207127 NA (low dose) | Experimental | Single dose of BI 207127 NA Receives: Drug: BI 207127 NA (low dose) |
| Matching placebo (low dose) | Placebo comparator | Single dose of matching placebo Receives: Drug: Matching placebo (low dose) |
| BI 207127 NA (medium dose) | Experimental | Single dose of BI 207127 NA Receives: Drug: BI 207127 NA (medium dose) |
| Matching placebo (medium dose) | Placebo comparator | Single dose of matching placebo Receives: Drug: Matching placebo (medium dose) |
| BI 207127 NA (high dose) | Experimental | Single dose of BI 207127 NA Receives: Drug: BI 207127 NA (high dose) |
| Matching placebo (high dose) | Placebo comparator | Single dose of matching placebo Receives: Drug: Matching placebo (high dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: From signing the informed consent (within 21 days before drug administration) until 14 days after end of trial visit, upto 38 days.
Secondary outcomes (12)
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-∞).
Measured: -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
Time from dosing to the maximum measured concentration of the analyte in plasma (Deleobuvir).
Measured: -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).
Measured: -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-∞.
Measured: -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) .
Measured: -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).
Measured: -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-∞.
Measured: -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).
Measured: -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).
Measured: -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-∞.
Measured: -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)".
Measured: -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)".
Measured: -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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347086
- Sponsor's protocol ID
- 1241.8
- Status last verified
- Mar 2016
- First submitted
- 3 May 2011
- Last updated
- 15 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (400mg, 800mg, 1200mg) of BI 207127 NA in Healthy Male Asian Volunteers and Single Oral Dose (1200 mg) of BI 207127 NA in Healthy Male Caucasian Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Group)
- ClinicalTrials.gov ID
- NCT01347086
- Acronym / sponsor ID
- 1241.8
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- First posted
- 4 May 2011 (estimated)
- Results
- Posted 15 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BI 207127 NA (low dose) | Experimental | Drug: BI 207127 NA (low dose)Single dose of BI 207127 NA |
| Matching placebo (low dose) | Placebo comparator | Drug: Matching placebo (low dose)Single dose of matching placebo |
| BI 207127 NA (medium dose) | Experimental | Drug: BI 207127 NA (medium dose)Single dose of BI 207127 NA |
| Matching placebo (medium dose) | Placebo comparator | Drug: Matching placebo (medium dose)Single dose of matching placebo |
| BI 207127 NA (high dose) | Experimental | Drug: BI 207127 NA (high dose)Single dose of BI 207127 NA |
| Matching placebo (high dose) | Placebo comparator | Drug: Matching placebo (high dose)Single dose of matching placebo |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers
- Chinese ethnicity or Japanese ethnicity or Caucasian
- Body Mass Index (BMI) = 18.5 and BMI =25 kg/m2 for Japanese and Chinese, BMI =18.5 and BMI = 29.9 kg/m2 for Caucasians
Key exclusion criteria (3 listed)
- Any finding of the medical examination (including Blood pressure(BP), Pulse rate (PR) and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Matching placebo (low dose)single dose of matching placebo | Drug | Matching placebo (low dose) |
| BI 207127 NA (medium dose)Single does of BI 207127 NA | Drug | BI 207127 NA (medium dose) |
| BI 207127 NA (low dose)single dose of BI 207127 NA | Drug | BI 207127 NA (low dose) |
| Matching placebo (medium dose)Single dose of matching placebo | Drug | Matching placebo (medium dose) |
| BI 207127 NA (high dose)Single dose of BI 207127 NA | Drug | BI 207127 NA (high dose) |
| Matching placebo (high dose)Single dose of matching placebo | Drug | Matching placebo (high dose) |
Primary outcome
Number of Subjects With Drug Related Adverse Events
Time frame: From first administration of study drug (drug related AEs) until 14 days after end of trial visit, upto 17 days.
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.
Number of Subjects With Adverse Events as Determined by Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG
Time frame: From signing the informed consent (within 21 days before drug administration) until 14 days after end of trial visit, upto 38 days.
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).
12 secondary outcomes
AUC0-∞ of Deleobuvir
Time frame: -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
Time frame: -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
Time frame: -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)
Time frame: -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 frame: -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)
Time frame: -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)
Time frame: -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 frame: -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)
Time frame: -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)
Time frame: -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 frame: -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)
Time frame: -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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related infoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 207127 NA (medium dose), BI 207127 NA (low dose) and BI 207127 NA (high dose) in people with Healthy, run by Boehringer Ingelheim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Drug Related Adverse Events (time frame: From first administration of study drug (drug related AEs) until 14 days after end of trial visit, upto 17 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.