Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1026706 in Male and Female Healthy Subjects and Patients With Osteoarthritis of the Knee

A Phase 1 study testing BI 1026706 in people with Osteoarthritis, 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 the safety and tolerability of BI 1026706 in male and female healthy subjects and osteoarthritis (OA) patients following oral administration of repeated rising doses To explore the pharmacokinetics after multiple rising doses of BI 1026706 in male and female healthy subjects and OA patients The… Read more about this study

Who is it for?: Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Osteoarthritis
What is being tested?: BI 1026706
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 58 participants
Where: 1 siteGermany
Study dates: 28 May 2014to 21 Oct 2014
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 35 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Males or females without any clinically relevant medical disorders according to the investigator's assessment, as based on the following: a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
For OA patients: Evidence of OA of the knee by radiography or by magnetic resonance tomography (Kellgren-Lawrence grade 1, 2, or 3; excluding grades 0 and 4) of the knee (tibiofemoral joint only) within the last 5 years consistent with the clinical diagnosis of osteoarthritis of the knee according to American College of Rheumatology (ACR) guidelines
For OA patients: American Rheumatism Association (ARA) functional class I, II, or III
For OA patients: Average pain in the index knee over the previous 48 hours greater than or equal to 4 on the 11-item Likert scale at two time points: 1) at screening (if not on analgesic medication) or after 3 days of wash-out of analgesic medication, and 2) in the evening prior to randomisation
For OA patients: Presence of bothersome OA related pain for most days within the last month prior to screening at the investigator's discretion, or pain requiring analgesic treatment on more than 3 days per week during the last month prior to screening.
Age 35 to 65 years (inclusive)

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BMI (Body Mass Index) 18.5 to 33 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Females who meet any of the following criteria from at least 30 days before the first study drug administration and until 30 days after trial completion:
using adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral contraceptives, intrauterine device (IUD)
sexually abstinent
have a vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
surgically sterilised (including hysterectomy)
postmenopausal defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH (Follicle Stimulating Hormon) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Who cannot join

Any finding in the medical examination (including Blood Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator
Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Trial locations and contacts

1 site in 1 country.

Germany1 site

1320.2.2 Boehringer Ingelheim Investigational Site
Berlin

Other trials in Germany

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1026706 in Male and Female Healthy Subjects and Patients With Osteoarthritis of the Knee (Randomised, Double-blind, Placebo-controlled Within the Dose Groups, Clinical Phase I)

To investigate the safety and tolerability of BI 1026706 in male and female healthy subjects and osteoarthritis (OA) patients following oral administration of repeated rising doses
To explore the pharmacokinetics after multiple rising doses of BI 1026706 in male and female healthy subjects and OA patients
The assessment of pharmacodynamics in OA patients

Conditions: Osteoarthritis
Being tested: BI 1026706, Placebo to BI 1026706
Medical subject headings: Osteoarthritis

What participants receive

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

BI 1026706Drug
Multiple Rising Doses (oral solution, tablet)
Placebo to BI 1026706Drug
Multiple Rising Doses (oral solution / tablet, identical to active treatment)

Study groups in NCT02126826
Study group	Role	What they receive
Placebo to BI 1026706	Placebo comparator	Multiple Rising Doses Placebo to BI 1026706 Receives: Drug: Placebo to BI 1026706
BI 1026706	Experimental	Multiple Rising Doses BI 1026706 Receives: Drug: BI 1026706

What is being measured

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

Percentage of Subjects With Drug Related Adverse Events
Percentage of subjects with drug related adverse events (AEs)
Measured: From first drug administration until 3 days after last drug administration, 15 days

Secondary outcomes (7)

Maximum Measured Concentration (Cmax)
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin
Time From Dosing to Maximum Measured Concentration (Tmax)
Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)
Measured: 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin.
Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 24h (AUC0-24)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24 hours (h) (AUC0-24).
Measured: 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin
Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 12h (AUC0-12)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 12 hours (h) (AUC0-12).
Measured: 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h and 12h after first drug admin
Maximum Measured Concentration at Steady-state (Cmax,ss)
Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval τ (Cmax,ss).
Measured: 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12
Time From Last Dosing to Maximum Measured Concentration at Steady-state (Tmax,ss)
Time from last dosing to maximum concentration of the analyte in plasma at steady-state (Tmax,ss).
Measured: 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12
Area Under the Concentration-time Curve at Steady-state (AUCτ,ss)
Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ (AUCτ,ss).
Measured: 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12

Timeline

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

28 May 201421 Oct 2014

First posted30 Apr 2014 (estimated)
Study start28 May 2014
Primary completion1 Oct 2014
Study completion21 Oct 2014

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 OsteoarthritisStudies 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: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02126826
Sponsor's protocol ID: 1320.2
Other IDs: 2012-005690-31
Status last verified: Dec 2018
First submitted: 28 Apr 2014
Last updated: 25 Mar 2019
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?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1026706 in Male and Female Healthy Subjects and Patients With Osteoarthritis of the Knee (Randomised, Double-blind, Placebo-controlled Within the Dose Groups, Clinical Phase I)
ClinicalTrials.gov ID: NCT02126826
Acronym / sponsor ID: 1320.2
Conditions: Osteoarthritis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 28 May 2014 (actual)
Primary completion: 1 Oct 2014 (actual)
Study completion: 21 Oct 2014 (actual)
First posted: 30 Apr 2014 (estimated)
Results: Posted 25 Mar 2019

Clinical summary

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

To investigate the safety and tolerability of BI 1026706 in male and female healthy subjects and osteoarthritis (OA) patients following oral administration of repeated rising doses
To explore the pharmacokinetics after multiple rising doses of BI 1026706 in male and female healthy subjects and OA patients
The assessment of pharmacodynamics in OA patients

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Placebo to BI 1026706	Placebo comparator	Drug: Placebo to BI 1026706Multiple Rising Doses Placebo to BI 1026706
BI 1026706	Experimental	Drug: BI 1026706Multiple Rising Doses BI 1026706

Who may qualify

Ages: 35 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Males or females without any clinically relevant medical disorders according to the investigator's assessment, as based on the following: a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
For OA patients: Evidence of OA of the knee by radiography or by magnetic resonance tomography (Kellgren-Lawrence grade 1, 2, or 3; excluding grades 0 and 4) of the knee (tibiofemoral joint only) within the last 5 years consistent with the clinical diagnosis of osteoarthritis of the knee according to American College of Rheumatology (ACR) guidelines
For OA patients: American Rheumatism Association (ARA) functional class I, II, or III
For OA patients: Average pain in the index knee over the previous 48 hours greater than or equal to 4 on the 11-item Likert scale at two time points: 1) at screening (if not on analgesic medication) or after 3 days of wash-out of analgesic medication, and 2) in the evening prior to randomisation
For OA patients: Presence of bothersome OA related pain for most days within the last month prior to screening at the investigator's discretion, or pain requiring analgesic treatment on more than 3 days per week during the last month prior to screening.

Key exclusion criteria (7 listed)

Any finding in the medical examination (including Blood Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator
Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

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 1026706Multiple Rising Doses (oral solution, tablet)	Drug	BI 1026706
Placebo to BI 1026706Multiple Rising Doses (oral solution / tablet, identical to active treatment)	Drug	Placebo to BI 1026706

Primary outcome

Percentage of Subjects With Drug Related Adverse Events
Time frame: From first drug administration until 3 days after last drug administration, 15 days
Percentage of subjects with drug related adverse events (AEs)

7 secondary outcomes

Maximum Measured Concentration (Cmax)
Time frame: 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin
Time From Dosing to Maximum Measured Concentration (Tmax)
Time frame: 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin.
Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 24h (AUC0-24)
Time frame: 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin
Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 12h (AUC0-12)
Time frame: 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h and 12h after first drug admin
Maximum Measured Concentration at Steady-state (Cmax,ss)
Time frame: 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12
Time From Last Dosing to Maximum Measured Concentration at Steady-state (Tmax,ss)
Time frame: 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12
Area Under the Concentration-time Curve at Steady-state (AUCτ,ss)
Time frame: 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12

Results and safety

Results posted to the registry on 25 Mar 2019, 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 HV	9	9
50mg BI 1026706 HV	9	9
100mg BI 1026706 HV	9	9
300mg BI 1026706 HV	9	8
Placebo OA	5	5
200mg BI 1026706 OA	9	9
100mg BI 1026706 BID OA	8	8

Primary outcome: Percentage of Subjects With Drug Related Adverse Events

Time frame: From first drug administration until 3 days after last drug administration, 15 days. Number. Unit: Percentage of participants

Measure	Placebo HV n = 9	50mg BI 1026706 HV n = 9	100mg BI 1026706 HV n = 9	300mg BI 1026706 HV n = 9	Placebo OA n = 5	200mg BI 1026706 OA n = 9	100mg BI 1026706 BID OA n = 8
Value	22.2	22.2	11.1	66.7	60.0	55.6	37.5

Population analysed: Treated set (TS)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 3 days after last drug administration, 15 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo HV	0 of 9 (0%)	5 of 9 (55.6%)	Not reported
50mg BI 1026706 HV	0 of 9 (0%)	3 of 9 (33.3%)	Not reported
100mg BI 1026706 HV	0 of 9 (0%)	2 of 9 (22.2%)	Not reported
300mg BI 1026706 HV	0 of 9 (0%)	6 of 9 (66.7%)	Not reported
Placebo OA	0 of 5 (0%)	3 of 5 (60%)	Not reported
200mg BI 1026706 OA	0 of 9 (0%)	6 of 9 (66.7%)	Not reported
100mg BI 1026706 BID OA	0 of 8 (0%)	4 of 8 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Osteoarthritis

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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 1026706 in people with Osteoarthritis, 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 14 inclusion and 7 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 25 Mar 2019. 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 25 Mar 2019). 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?

Percentage of Subjects With Drug Related Adverse Events (time frame: From first drug administration until 3 days after last drug administration, 15 days). 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 NCT02126826.

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 25 Mar 2019.