Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Safety, Tolerability Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 409306 Film-coated Tablets Given Orally q.d. or Bid for 14 Days in Young Healthy and Elderly Healthy Male/Female Volunteers (Randomised, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)

ClinicalTrials.gov ID

NCT01505894

Acronym / sponsor ID

1289.2

Conditions

Healthy

Phase

Phase 1

Study type

Interventional

Recruitment status

Completed

Enrolment

83 participants (actual)

Lead sponsor

Boehringer IngelheimIndustry (pharma, biotech, devices)

Study start

1 Jan 2012 (actual)

Primary completion

1 Jul 2012 (actual)

Study completion

1 Jul 2012 (actual)

First posted

9 Jan 2012 (estimated)

Results

Posted 8 Mar 2024

Clinical summary

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

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Single group

Masking

Double blind

Number of arms

9

Who may qualify

Ages

21 to 80 years

Sex

All

Healthy volunteers

Accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group

   Time frame: From first drug administration until the end-of-trial examination, up to 28 days.

   An adverse event is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a subject in a clinical investigation who received a pharmaceutical product.

2. Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment

   Time frame: From first drug administration until the end-of-trial examination, up to 28 days.

   Number of participants with clinically relevant abnormal findings, as judged by investigator and reported as adverse event (AE), in vital signs (blood pressure, pulse rate, orthostatic test), 12-lead electrocardiogram (ECG), clinical laboratory tests (haematology, clinical chemistry, urinalysis) , physical examination, ophthalmological examination and suicidality assessment.

3. Number of Participants Per Category of Global Tolerability Assessed by the Investigator

   Time frame: From first drug administration until the end-of-trial examination, up to 28 days.

   The investigator assessed tolerability based on adverse events and the laboratory evaluation and classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'. Investigator judgement based on clinical findings: "good" - No or mild adverse events (AEs) and no clinically significant (NCS) findings in any clinical assessments; "satisfactory" - mild or moderate AEs, NCS clinical findings; "not satisfactory" - moderate/severe AEs and/or clinically significant (CS) findings.

4. Number of Participants With Abnormal Findings in Color Discrimination Test

   Time frame: From first drug administration until the end-of-trial examination, up to 28 days.

   Color vision was tested using the Ishihara test for color deficiency. The test consisted of a number of plates, called Ishihara plates, each of which contains a circle of dots of differing color and size. Within the pattern some dots form a number visible to those with normal color vision and invisible, or difficult to see, for those with a color vision deficiency. Participants with abnormal findings in color discrimination test are participants, who are not able to recognize the sign on the presented table.

5. Number of Participants With Abnormal Findings in Visual Acuity Test

   Time frame: From first drug administration until the end-of-trial examination, up to 28 days.

   Snellen chart was used to measure visual acuity. It measures the smallest line that a participant was able to read at a distance of 3 meter. Participants with abnormal findings in visual acuity test are participants, who are not able to recognize the letters on the line 3.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Related InfoLink provided by the sponsor.
• Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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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.

1 site in 1 country: see every site and its status.