HealthyPhase 1NCT01843972

Safety of Single Rising Doses and Relative Bioavailability of BI 691751

A Phase 1 study testing BI 691751 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I). To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution (part II) Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 691751
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 81 participants
Where: 1 siteGermany
Study dates: Apr 2013to Nov 2013
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 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects
Subjects must be able to understand and comply with study requirements
Age from 18 to 55 years
BMI range: from 18.5 to 29.9 kg/m2
Known genotype as specified in the study protocol

Who cannot join

1. Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1334.1.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 691751 in Healthy Male Volunteers in a Randomised, Single-blind, Placebo-controlled Design (Part I) and Investigation of Relative Bioavailability of BI 691751 Given as Tablet and Oral Solution to Healthy Male Subjects in an Open, Randomised, Single-dose, Single Period Parallel Group Design (Part II).

To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I).

To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution (part II)

Conditions: Healthy
Being tested: BI 691751, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 691751Drug
oral solution BI 691751, dose 6
BI 691751Drug
oral solution
PlaceboDrug
placebo solution
BI 691751Drug
oral solution BI 691751, dose 2
BI 691751Drug
oral solution BI 691751, dose 5
BI 691751Drug
1 tablet
BI 691751Drug
oral solution BI 691751, dose 3
BI 691751Drug
oral solution BI 69175, dose 4
BI 691751Drug
oral solution BI 691751, dose 7
BI 691751Drug
oral solution BI 69175, dose 1

Study groups in NCT01843972
Study group	Role	What they receive
BI 691751 dose 2 (part I)	Experimental	single dose given as oral solution Receives: Drug: BI 691751
BI 691751 dose 3 (part I)	Experimental	single dose given as oral solution Receives: Drug: BI 691751
BI 691751 dose 4 (part I)	Experimental	single dose given as oral solution Receives: Drug: BI 691751
BI 691751 dose 5 (part I)	Experimental	single dose given as oral solution Receives: Drug: BI 691751
BI 691751 dose 6 (part I)	Experimental	single dose given as oral solution Receives: Drug: BI 691751
BI 691751 dose 7 (part I)	Experimental	single dose given as oral solution Receives: Drug: BI 691751
BI 691751dose 1 (part I)	Experimental	single dose given as oral solution Receives: Drug: BI 691751
Placebo (part I)	Placebo comparator	placebo solution Receives: Drug: Placebo
BI 691751 tablet (part II)	Experimental	single dose given as 1 tablet Receives: Drug: BI 691751
BI 691751 solution (part II)	Active comparator	single dose given as oral solution Receives: Drug: BI 691751

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC0-72h (Part II)
AUC0-72h (area under the concentration-time curve of the analyte of BI 691751 in plasma over the time interval from 0 to 72 h) (part II).
PPS-BA included all subjects in the TS who were randomised to the BA part, who provided at least one observation for at least one primary endpoint, had no important protocol violations relevant for the statistical evaluation of BA and did not experience emesis at or before twice the median tmax.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration
Cmax (Part II)
Cmax (maximum measured concentration of the analyte of BI 691751 in plasma) (part II)
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug administration
Frequency of Subjects With Drug-related Adverse Events (Part I)
Frequency of subjects with drug-related Adverse Events (AEs) (Part I)
Measured: Part I: 'Day1 to Day21 for Dose 1, 2,3 &4 and Day1 to Day45 for Dose group 5,6 & 7

Secondary outcomes (5)

Cmax (Part I)
Cmax (maximum measured concentration of BI 691751 in plasma) (part I)
Time frame:
Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin
Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin
Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin
Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin
Measured: for dose 1 & 2: up to 168h, for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h
AUC0-infinity (Part I)
AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma over the time interval from 0 extrapolated to infinity) (part I)
Time frame:
Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin
Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin
Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin
Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin
Measured: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h
AUC0-tz
AUC0-tz (area under the concentration-time curve of BI 691751 in plasma over the time interval from 0 up to the last quantifiable data point) (Part I and Part II)
Time frame:
Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin
Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin
Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin
Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin
Measured: Part 1: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 7: up to 720h; Part 2: up to 720h
t1/2 (Part I)
t1/2 (terminal half-life of the analyte of BI 691751 in plasma) (part I)
Time frame:
Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin
Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin
Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin
Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin
Measured: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h
Tmax (Part I)
tmax (time from dosing to maximum measured concentration of BI 691751) (part I)
Time frame:
Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin
Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin
Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin
Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin
Measured: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Nov 2013

First posted1 May 2013 (estimated)
Study startApr 2013
Primary completionNov 2013
Study completionNov 2013

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: Single blind
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01843972
Sponsor's protocol ID: 1334.1
Other IDs: 2012-005721-67
Status last verified: May 2016
First submitted: 29 Apr 2013
Last updated: 27 Jun 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2016. 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 of BI 691751 in Healthy Male Volunteers in a Randomised, Single-blind, Placebo-controlled Design (Part I) and Investigation of Relative Bioavailability of BI 691751 Given as Tablet and Oral Solution to Healthy Male Subjects in an Open, Randomised, Single-dose, Single Period Parallel Group Design (Part II).
ClinicalTrials.gov ID: NCT01843972
Acronym / sponsor ID: 1334.1
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 1 May 2013 (estimated)
Results: Posted 29 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I).

To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution (part II)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Number of arms: 10

Arm	Type	Receives
BI 691751 dose 2 (part I)	Experimental	Drug: BI 691751single dose given as oral solution
BI 691751 dose 3 (part I)	Experimental	Drug: BI 691751single dose given as oral solution
BI 691751 dose 4 (part I)	Experimental	Drug: BI 691751single dose given as oral solution
BI 691751 dose 5 (part I)	Experimental	Drug: BI 691751single dose given as oral solution
BI 691751 dose 6 (part I)	Experimental	Drug: BI 691751single dose given as oral solution
BI 691751 dose 7 (part I)	Experimental	Drug: BI 691751single dose given as oral solution
BI 691751dose 1 (part I)	Experimental	Drug: BI 691751single dose given as oral solution
Placebo (part I)	Placebo comparator	Drug: Placeboplacebo solution
BI 691751 tablet (part II)	Experimental	Drug: BI 691751single dose given as 1 tablet
BI 691751 solution (part II)	Active comparator	Drug: BI 691751single dose given as oral solution

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy male subjects
Subjects must be able to understand and comply with study requirements
Age from 18 to 55 years
BMI range: from 18.5 to 29.9 kg/m2
Known genotype as specified in the study protocol

Key exclusion criteria (1 listed)

1. Any relevant deviation from healthy conditions

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 691751oral solution BI 691751, dose 6	Drug	BI 691751 dose 6 (part I)
BI 691751oral solution	Drug	BI 691751 solution (part II)
Placeboplacebo solution	Drug	Placebo (part I)
BI 691751oral solution BI 691751, dose 2	Drug	BI 691751 dose 2 (part I)
BI 691751oral solution BI 691751, dose 5	Drug	BI 691751 dose 5 (part I)
BI 6917511 tablet	Drug	BI 691751 tablet (part II)
BI 691751oral solution BI 691751, dose 3	Drug	BI 691751 dose 3 (part I)
BI 691751oral solution BI 69175, dose 4	Drug	BI 691751 dose 4 (part I)
BI 691751oral solution BI 691751, dose 7	Drug	BI 691751 dose 7 (part I)
BI 691751oral solution BI 69175, dose 1	Drug	BI 691751dose 1 (part I)

Primary outcome

AUC0-72h (Part II)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration
AUC0-72h (area under the concentration-time curve of the analyte of BI 691751 in plasma over the time interval from 0 to 72 h) (part II). PPS-BA included all subjects in the TS who were randomised to the BA part, who provided at least one observation for at least one primary endpoint, had no important protocol violations relevant for the statistical evaluation of BA and did not experience emesis at or before twice the median tmax.
Cmax (Part II)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug administration
Cmax (maximum measured concentration of the analyte of BI 691751 in plasma) (part II)
Frequency of Subjects With Drug-related Adverse Events (Part I)
Time frame: Part I: 'Day1 to Day21 for Dose 1, 2,3 &4 and Day1 to Day45 for Dose group 5,6 & 7
Frequency of subjects with drug-related Adverse Events (AEs) (Part I)

5 secondary outcomes

Cmax (Part I)
Time frame: for dose 1 & 2: up to 168h, for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h
AUC0-infinity (Part I)
Time frame: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h
AUC0-tz
Time frame: Part 1: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 7: up to 720h; Part 2: up to 720h
t1/2 (Part I)
Time frame: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h
Tmax (Part I)
Time frame: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h

Results and safety

Results posted to the registry on 29 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (Part I)	13	13
BI 691751 Dose 1 (Part I)	6	6
BI 691751 Dose 2 (Part I)	5	5
BI 691751 Dose 3 (Part I)	6	6
BI 691751 Dose 4 (Part I)	6	5
BI 691751 Dose 5 (Part I)	6	6
BI 691751 Dose 6 (Part I)	5	5
BI 691751 Dose 7 (Part I)	5	5
BI 691751 Tablet (Part II)	17	17
BI 691751 Solution (Part II); Extensive Metabolizers	12	12

Primary outcome: AUC0-72h (Part II)

Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	BI 691751 Tablet Extensive Metabolizers (Part II) n = 12	BI 691751 Tablet Poor Metabolizers (Part II) n = 5	BI 691751 Solution (Part II); Extensive Metabolizers n = 7
Value	2740 (26.1)	3050 (20.5)	2800 (22.2)

BI 691751 Tablet Extensive Metabolizers (Part II) vs BI 691751 Solution (Part II); Extensive Metabolizers: Geometric mean ratio (net): 97.88 (90% CI 79.963 to 119.809), ANOVA
BI 691751 Tablet Extensive Metabolizers (Part II) vs BI 691751 Tablet Poor Metabolizers (Part II): Geometric mean ratio (net): 111.20 (90% CI 88.596 to 139.576), ANOVA

Population analysed: Per protocol set for evaluation of bioavailability (PPS-BA). Only subjects with calculable PK parameter were analysed.

Primary outcome: Cmax (Part II)

Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	BI 691751 Tablet Extensive Metabolizers (Part II) n = 12	BI 691751 Tablet Poor Metabolizers (Part II) n = 5	BI 691751 Solution (Part II); Extensive Metabolizers n = 7
Value	223 (33.6)	207 (31.3)	220 (14.4)

BI 691751 Tablet Extensive Metabolizers (Part II) vs BI 691751 Solution (Part II); Extensive Metabolizers: Geometric mean ratio (net): 101.31 (90% CI 80.593 to 127.351), ANOVA
BI 691751 Tablet Extensive Metabolizers (Part II) vs BI 691751 Tablet Poor Metabolizers (Part II): Geometric mean ratio (net): 92.69 (90% CI 68.662 to 125.119), ANOVA

Population analysed: PPS-BA. Only subjects with calculable PK parameter were analysed.

Primary outcome: Frequency of Subjects With Drug-related Adverse Events (Part I)

Time frame: Part I: 'Day1 to Day21 for Dose 1, 2,3 &4 and Day1 to Day45 for Dose group 5,6 & 7. Number. Unit: Participants

Measure	Placebo (Part I) n = 13	BI 691751 Dose 1 (Part I) n = 6	BI 691751 Dose 2 (Part I) n = 5	BI 691751 Dose 3 (Part I) n = 6	BI 691751 Dose 4 (Part I) n = 6	BI 691751 Dose 5 (Part I) n = 6	BI 691751 Dose 6 (Part I) n = 5	BI 691751 Dose 7 (Part I) n = 5
Value	1	0	1	0	0	0	0	1

Population analysed: Treated Set (TS): all subjects who were documented to have taken at least 1 dose of study medication.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Part I)	0 of 13 (0%)	5 of 13 (38.5%)	Not reported
BI 691751 Dose 1 (Part I)	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
BI 691751 Dose 2 (Part I)	0 of 5 (0%)	2 of 5 (40%)	Not reported
BI 691751 Dose 3 (Part I)	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
BI 691751 Dose 4 (Part I)	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
BI 691751 Dose 5 (Part I)	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
BI 691751 Dose 6 (Part I)	0 of 5 (0%)	3 of 5 (60%)	Not reported
BI 691751 Dose 7 (Part I)	0 of 5 (0%)	4 of 5 (80%)	Not reported
BI 691751 Tablet (Part II)	0 of 17 (0%)	5 of 17 (29.4%)	Not reported
BI 691751 Solution (Part II); Extensive Metabolizers	1 of 12 (8.3%)	3 of 12 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 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 691751 in people with 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 5 inclusion and 1 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 27 Jun 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 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?

Yes. Results are posted in the registry (first posted 29 Feb 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?

AUC0-72h (Part II) (time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01843972.

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 27 Jun 2016.