HealthyPhase 1NCT01195688
Safety and Tolerability of BI 638683 After Single Rising Oral Doses in Healthy Male Subjects
A Phase 1 study of Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The primary objective of the current study is to investigate the safety and tolerability of BI 638683 in healthy male volunteers following oral administration of single rising doses Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male subjects
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1-700 mg) of BI 638683 Powder in Bottle (PiB) in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
The primary objective of the current study is to investigate the safety and tolerability of BI 638683 in healthy male volunteers following oral administration of single rising doses
- Conditions
- Healthy
- Being tested
- BI 638683 or placebo, Placebo solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 638683 or placeboDrug
oral doses given to 6 subjects per dose group
Placebo solutionDrug
oral doses given to 2 subjects per dose group
| Study group | Role | What they receive |
|---|---|---|
| BI 638683 | Experimental | 1 single dose per subject as oral solution Receives: Drug: BI 638683 or placebo |
| Placebo solution | Placebo comparator | 1 single dose per subject as oral solution Receives: Drug: Placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of BI 638683 will be assessed in a descriptive way.
Measured: up to 14 days post treatment
Tolerability of BI 638683 will be assessed in a descriptive way.
Measured: up to 14 days post treatment
Secondary outcomes (2)
To assess pharmacodynamics of BI 638683.
Measured: up to 5 days post study drug administration
To assess pharmacokinetics of BI 638683.
Measured: up to 5 days post study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- Double blind
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195688
- Sponsor's protocol ID
- 1279.1
- Other IDs
- 2010-021187-15
- Status last verified
- Jun 2011
- First submitted
- 3 Sep 2010
- Last updated
- 2 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1-700 mg) of BI 638683 Powder in Bottle (PiB) in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
- ClinicalTrials.gov ID
- NCT01195688
- Acronym / sponsor ID
- 1279.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- First posted
- 6 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the current study is to investigate the safety and tolerability of BI 638683 in healthy male volunteers following oral administration of single rising doses
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 638683 | Experimental | Drug: BI 638683 or placebo1 single dose per subject as oral solution |
| Placebo solution | Placebo comparator | Drug: Placebo solution1 single dose per subject as oral solution |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy male subjects
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BI 638683 or placebooral doses given to 6 subjects per dose group | Drug | BI 638683 |
| Placebo solutionoral doses given to 2 subjects per dose group | Drug | Placebo solution |
Primary outcome
Safety of BI 638683 will be assessed in a descriptive way.
Time frame: up to 14 days post treatment
Tolerability of BI 638683 will be assessed in a descriptive way.
Time frame: up to 14 days post treatment
2 secondary outcomes
To assess pharmacodynamics of BI 638683.
Time frame: up to 5 days post study drug administration
To assess pharmacokinetics of BI 638683.
Time frame: up to 5 days post study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 of Healthy, run by Boehringer Ingelheim at 1 site in Germany.
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 1 inclusion and 0 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 2 Jun 2011. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of BI 638683 will be assessed in a descriptive way. (time frame: up to 14 days post treatment). 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 2 Jun 2011.