Safety and Pharmacokinetics of Multiple Rising Oral Doses of BI 224436 in Healthy Male Volunteers.

NCT01276990 | Withdrawn Phase 1

• 1 other identifier: 1277.2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the safety and pharmacokinetic of BI 224436 in healthy male volunteers following oral administration of repeated doses for 10 days within 8 dosing regimens.

Conditions

HIV Infections; Healthy

Outcome Measures

Primary Outcomes (5)

• Changes in blood pressure

  1 month

• Changes in pulse rate

  1 month

• Changes in 12-lead ECG

  1 month

• Changes in clinical laboratory test parameters

  1 month

• Adverse events

  1 month

Secondary Outcomes (6)

• Cmax,ss (maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval t)

  10 days

• tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady-state)

  10 Days

• Cmin,ss (minimum concentration of the analyte in plasma at steady-state over a uniform dosing interval t)

  10 days

• AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval t)

  13 days

• t1/2,ss (terminal half-life of the analyte in plasma at steady-state)

  13 days

Study Arms (9)

Placebo

PLACEBO COMPARATOR

Matching placebo in dosing regimen 1-8

Drug: BI 224436; Drug: Placebo

BI 224436 dosing regimen 1

EXPERIMENTAL

Dosing regimen 1

Drug: BI 224436

BI 224436 dosing regimen 2

EXPERIMENTAL

Dosing regimen 2

Drug: BI 224436

BI 224436 dosing regimen 3

EXPERIMENTAL

Dosing regimen 3

Drug: BI 224436

BI 224436 dosing regimen 4

EXPERIMENTAL

Dosing regimen 4

Drug: BI 224436

BI 224436 dosing regimen 5

EXPERIMENTAL

Dosing regimen 5

Drug: BI 224436

BI 224436 dosing regimen 6

EXPERIMENTAL

Dosing regimen 6

Drug: BI 224436

BI 224436 dosing regimen 7

EXPERIMENTAL

Dosing regimen 7

Drug: BI 224436

BI 224436 dosing regimen 8

EXPERIMENTAL

Dosing regimen 8

Drug: BI 224436

Interventions

BI 224436 DRUG

Oral drinking solution

BI 224436 dosing regimen 6

Placebo DRUG

Oral drinking solution

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male 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 \>=18 and \<=50 years.
• Body Mass Index (BMI) \>=18.5 and BMI \<=32 kg/m2.
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.
• Documented to be sterile; or, if can father a child, agree to abstain from sexual intercourse during and at least seven days following last study drug administration, or are willing to use condoms during the same period each time (Subject's female sexual partner(s) of child-bearing potential should be willing to use either ethinyl estradiol containing oral contraceptives or a reliable barrier method of contraception).

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance according to the opinion of the investigator.
• Any evidence of a clinically relevant concomitant disease.
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
• Surgery of the gastrointestinal tract that in the opinion of the investigator may affect the absorption.
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
• History of relevant orthostatic hypotension, fainting spells or blackouts.
• History or evidence of Human Immunodeficiency Virus or other chronic or relevant acute infections, including Hepatitis C Virus and Hepatitis B Virus infection.
• History of relevant allergy / hypersensitivity (including allergy to investigational medicinal product or its solvent).
• History of any familial skeletal muscle disorder, or history of Creatine Kinase (CK) elevation not due to strenuous physical activity or trauma.
• Intake of 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, including prescription and non-prescription drugs, and St. Johns Wort which might reasonably influence the results of the trial within 14 days prior to study drug administration or during the trial, or consumption of grapefruit, grapefruit juice, orange juice, Seville oranges, green tea, pineapple, pineapple juice, broccoli or red wine within 3 days prior study drug administration or during the trial.
• Participation in another trial with an investigational drug within one month prior to administration or during the trial.
• Current smoker (\>10 cigarettes or \>3 cigars or \>3 pipes / day).
• Inability to refrain from smoking during the trial.
• Alcohol abuse (more than 30 g day).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 14, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2012
• Last Updated: February 9, 2012

Record last verified: 2012-02