Safety, Pharmacokinetics and Pharmacodynamics of BIRT 1696 BS in Healthy Human Subjects

NCT02254096 | Completed Phase 1

• 1 other identifier: 1195.1
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objectives are:

1. 1.To assess safety, pharmacokinetics, and pharmacodynamics of BIRT 1696 BS in rising single doses.
2. 2.To assess safety, pharmacokinetics, and pharmacodynamics of single dose of 100 mg BIRT 1696 BS after grapefruit juice.
3. 3.To asses safety and pharmacokinetics of single dose of 400 mg BIRT 1696 BS after a 67 g fat and high caloric breakfast.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of subjects with adverse events

  up to 44 days

• Number of subjects with clinically significant changes in vital signs

  up to 44 days

• Number of subjects with abnormal changes in laboratory parameters

  up to 44 days

• Number of subjects with abnormal findings in electrocardiogram

  up to 44 days

• Number of subjects with abnormal findings in physical examination

  up to 44 days

• Assessment of tolerability on a verbal rating scale

  up to 44 days

Secondary Outcomes (10)

• Maximum observed plasma concentration (Cmax)

  up to 48 hours after drug administration

• Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞)

  up to 48 hours after drug administration

• Time to the maximum plasma concentration (tmax)

  up to 48 hours after drug administration

• Elimination half-life (t1/2)

  up to 48 hours after drug administration

• Total apparent oral clearance of drug from plasma after oral administration (CL/F)

  up to 48 hours after drug administration

Study Arms (4)

BIRT 1696 BS

EXPERIMENTAL

single escalating dose phase

Drug: BIRT 1696 BS

BIRT 1696 BS + GFJ

EXPERIMENTAL

single dose grapefruit effect arm

Drug: BIRT 1696 BS; Other: Grapefruit juice (GFJ)

BIRT 1696 BS + HFM

EXPERIMENTAL

single dose food effect arm

Drug: BIRT 1696 BS; Other: High fat meal (HFM)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIRT 1696 BS DRUG

BIRT 1696 BS; BIRT 1696 BS + GFJ; BIRT 1696 BS + HFM

Placebo DRUG

Placebo

Grapefruit juice (GFJ) OTHER

BIRT 1696 BS + GFJ

High fat meal (HFM) OTHER

BIRT 1696 BS + HFM

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects as determined by results of screening
• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age ≥18 and ≤60 years
• Body Mass Index ≥18.5 and ≤29.9 kg/m2

You may not qualify if:

• Female subjects who are lactating or of child bearing potential as defined by surgically sterile or post menopausal (no periods for at least 12 months and elevated follicle stimulating hormone with low estradiol while on no estrogen supplementation unless surgically sterile). Females should use barrier contraception (e.g. condoms) prior to administration of study medication, during the study and at least one month after release from the study. Women must have had negative blood pregnancy tests
• Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• Relevant history of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant 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) (\< 1 month prior to administration or during the trial)
• Use of any drugs, which might influence the results of the trial, (\< 10 days prior to administration or during the trial)
• Participation in another trial with an investigational drug (\< 2 months prior to administration or during trial)
• Smoker (\> 10 cigarettes or \>3 cigars or \>3 pipes/day)
• Alcohol abuse (\> 60 g/day)
• Drug abuse
• Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco \< 5 days prior to administration of study drug or during trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: September 30, 2014
• First Posted: October 1, 2014
• Study Start: May 1, 2002
• Primary Completion: July 1, 2002
• Last Updated: October 1, 2014

Record last verified: 2014-09