Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-01

Study Completion Date

2012-07-01

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Placebo - Young Subjects

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Film-coated tablet

Placebo - Elderly Subjects

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Film-coated tablet

BI 409306 25 mg - Young Subjects QD

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

Group Type EXPERIMENTAL

BI 409306

Intervention Type DRUG

Film-coated tablet

BI 409306 25 mg - Elderly Subjects QD

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

Group Type EXPERIMENTAL

BI 409306

Intervention Type DRUG

Film-coated tablet

BI 409306 50 mg - Young Subjects QD

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

Group Type EXPERIMENTAL

BI 409306

Intervention Type DRUG

Film-coated tablet

BI 409306 50 mg - Young Subjects BID

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

Group Type EXPERIMENTAL

BI 409306

Intervention Type DRUG

Film-coated tablet

BI 409306 50 mg - Elderly Subjects QD

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

Group Type EXPERIMENTAL

BI 409306

Intervention Type DRUG

Film-coated tablet

BI 409306 100 mg - Young Subjects QD

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

Group Type EXPERIMENTAL

BI 409306

Intervention Type DRUG

Film-coated tablet

BI 409306 100 mg - Elderly Subjects QD

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

Group Type EXPERIMENTAL

BI 409306

Intervention Type DRUG

Film-coated tablet

Interventions

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BI 409306

Film-coated tablet

Intervention Type DRUG

Placebo

Film-coated tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Age \>21 and Age \<50 years for young healthy volunteers or Age \>65 and Age \<80 years for elderly healthy volunteers
3. BMI \>18.5 and BMI \<29.9 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
5. 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.

Exclusion Criteria

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)
6. 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.
7. Chronic or relevant acute infections
8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
9. 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
10. 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
11. Participation in another trial with an investigational drug within four weeks prior to administration or during the trial
12. Smoker (\> 5 cigarettes or \> 1 cigars or \> 1 pipes/day)
13. Inability to refrain from smoking on trial days
14. Alcohol abuse (more than 20 g/day)
15. Drug abuse
16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
17. Excessive physical activities (within one week prior to administration or during the trial)
18. Any laboratory value outside the reference range that is of clinical relevance in the judgment of investigator
19. Inability to comply with dietary regimen of trial site
20. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc F interval \>430 ms in males and \>450 ms in females);
21. A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes