Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses

NCT01505894 | Completed Phase 1 Results

• 2 other identifiers: 1289.22011-002369-39
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial was to investigate safety and tolerability of multiple doses of BI 409306 in healthy young and elderly volunteers. The secondary objective was to explore the pharmacokinetics and pharmacodynamics of multiple doses of BI 409306 in healthy young and elderly volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

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

  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.

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

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

  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.

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

• Number of Participants Per Category of Global Tolerability Assessed by the Investigator

  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.

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

• Number of Participants With Abnormal Findings in Color Discrimination Test

  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.

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

• Number of Participants With Abnormal Findings in Visual Acuity Test

  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.

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

Secondary Outcomes (6)

• Maximum Concentration of BI 409306 in Plasma (Cmax)

  On day 1, at -2:00 hours (pre dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.

• Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax)

  On day 1, at -2:00 hours (pre-dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.

• Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  On day 1, at -2:00 hours (pre-dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.

• Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)

  At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment.

• Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss)

  At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment.

Study Arms (9)

Placebo - Young Subjects

PLACEBO COMPARATOR

Placebo - Young Subjects

Drug: Placebo

Placebo - Elderly Subjects

PLACEBO COMPARATOR

Placebo - Elderly Subjects

Drug: Placebo

BI 409306 25 mg - Young Subjects QD

EXPERIMENTAL

25 milligram (mg) of BI 409306 were administered in young subjects once daily (QD).

Drug: BI 409306

BI 409306 25 mg - Elderly Subjects QD

EXPERIMENTAL

25 mg of BI 409306 were administered in elderly subjects once daily (QD).

Drug: BI 409306

BI 409306 50 mg - Young Subjects QD

EXPERIMENTAL

50 mg of BI 409306 were administered in young subjects once daily (QD).

Drug: BI 409306

BI 409306 50 mg - Young Subjects BID

EXPERIMENTAL

50 mg of BI 409306 were administered in young subjects twice daily (BID).

Drug: BI 409306

BI 409306 50 mg - Elderly Subjects QD

EXPERIMENTAL

50 mg of BI 409306 were administered in elderly subjects once daily

Drug: BI 409306

BI 409306 100 mg - Young Subjects QD

EXPERIMENTAL

100 mg of BI 409306 were administered in young subjects once daily (QD).

Drug: BI 409306

BI 409306 100 mg - Elderly Subjects QD

EXPERIMENTAL

100 mg of BI 409306 were administered in elderly subjects once daily (QD).

Drug: BI 409306

Interventions

BI 409306 DRUG

Film-coated tablet

BI 409306 100 mg - Elderly Subjects QD; BI 409306 100 mg - Young Subjects QD; BI 409306 25 mg - Elderly Subjects QD; BI 409306 25 mg - Young Subjects QD; BI 409306 50 mg - Elderly Subjects QD; BI 409306 50 mg - Young Subjects BID; BI 409306 50 mg - Young Subjects QD

Placebo DRUG

Film-coated tablet

Placebo - Elderly Subjects; Placebo - Young Subjects

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
• Age \>21 and Age \<50 years for young healthy volunteers or Age \>65 and Age \<80 years for elderly healthy volunteers
• BMI \>18.5 and BMI \<29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
• For female subjects: Female subjects must be surgically sterilized or postmenopausal. Surgical sterilization or hysterectomy must have occurred at least 6 months prior to screening. Menopausal women must have no regular menstrual bleeding for at least 2 years prior to screening.

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)
• History or evidence of relevant orthostatic reaction (drop in systolic blood pressure (SBP) \>20 mm Hg and increase in heart rate \> 30 bpm after 2 minutes standing relative to supine data), fainting spells or blackouts.
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of any drugs within 14 days or 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
• Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within four weeks prior to administration or during the trial
• Smoker (\> 5 cigarettes or \> 1 cigars or \> 1 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 20 g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1289.2.1 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

BI 409306

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 9, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 8, 2024
• Results First Posted: March 8, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)