Influence of Clopidogrel on the Pharmacodynamics and Safety of Terbogrel in Healthy Male Subjects

NCT02222987 | Completed Phase 1

• 1 other identifier: 528.23
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100 mg terbogrel bid.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Change in inhibition of platelet aggregation in platelet rich plasma (PRP)

  baseline, up to day 17

• Change in thromboxane receptor occupancy (TRO)

  baseline, up to day 17

• Change in 6-keto-prostaglandinF-1-alpha

  baseline, up to day 17

• Change in thromboxan synthesis inhibition (TSI)

  baseline, up to day 17

Secondary Outcomes (8)

• Plasma levels of terbogrel

  up to day 17

• Number of patients with adverse events

  up to day 17

• Change in bleeding time

  baseline, up to day 17

• Change in systolic and diastolic blood pressure

  baseline, up to day 17

• Change in pulse rate

  baseline, up to day 17

Study Arms (3)

Terbogrel

ACTIVE COMPARATOR

Drug: Terbogrel

Terbogrel with Clopidogrel

EXPERIMENTAL

Drug: Terbogrel; Drug: Clopidogrel

Clopidogrel

ACTIVE COMPARATOR

Drug: Clopidogrel

Interventions

Terbogrel DRUG

Terbogrel; Terbogrel with Clopidogrel

Clopidogrel DRUG

Clopidogrel; Terbogrel with Clopidogrel

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Healthy male subjects
• Age \>= 18 and \<= 45 years
• Broca \>= -20% and \<= +20 %

You may not qualify if:

• Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
• Chronic or relevant acute infections
• History of
• allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• any bleeding disorder including prolonged or habitual bleeding
• other hematologic disease
• cerebral bleeding (e.g. after car accident)
• commotio cerebri
• Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
• Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within 2 months days prior to administration or during the trial
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

terbogrel; Clopidogrel

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 22, 2014
• Study Start: February 1, 1999
• Primary Completion: March 1, 1999
• Last Updated: August 22, 2014

Record last verified: 2014-08