Bioavailability of Four Oral Prototype Extended Release Formulations With BI 11634 in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 11634 ER formulation C; Drug: BI 11634 ER formulation M; Drug: BI 11634 ER formulation B; Drug: BI 11634 IR tablet; Drug: BI 11634 ER formulation A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02214953

1234.7

Details and patient eligibility

About

To compare the oral bioavailability and rate of absorption of four prototype extended-release (ER) formulations with BI 11634 (single doses) to immediate-release (IR) tablets in healthy male volunteers.

Enrollment: 17 patients

Sex: Male

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Caucasian males according to the following criteria, based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, clinical laboratory tests
• Age ≥21 and ≤45 years
• Haemoglobin within the normal ranges.
• Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation

Exclusion criteria

• Relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Relevant surgery of gastrointestinal tract
• History of any bleeding disorder or acute blood coagulation defect, for the subject itself or any person of his family as far as known
• History of gastric ulcera and cholecystectomy
• Occult blood in faeces
• Relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Relevant chronic or acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• 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 which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Use of acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks of study start until the end of study
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Alcohol abuse (more than 40 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)
• Any laboratory value outside the reference range that is of clinical relevance
• Inability to understand and comply with protocol requirements, instructions and protocol stated restrictions, the nature, scope and possible consequences of the study
• Subjects with a history within the past six weeks of closed-head or torso trauma or deceleration injury such as an automobile accident or fall from a significant height

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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17 participants in 5 patient groups

BI 11634 ER formulation A

Experimental group

Treatment:

Drug: BI 11634 ER formulation A

BI 11634 ER formulation B

Experimental group

Treatment:

Drug: BI 11634 ER formulation B

BI 11634 ER formulation M

Experimental group

Treatment:

Drug: BI 11634 ER formulation M

BI 11634 ER formulation C

Experimental group

Treatment:

Drug: BI 11634 ER formulation C

BI 11634 IR tablet

Active Comparator group

Treatment:

Drug: BI 11634 IR tablet