Study to Investigate if the Uptake of Ticagrelor Into the Body Differs Depending on Method of Administration.

NCT01887626 | Completed Phase 1

• 1 other identifier: D5130C00076
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Study to investigate if the uptake of Ticagrelor into the body differs depending on method of administration.

Conditions

Bioavailability Heathy Volunteers

Keywords

Phase 1, pharmacokinetic, safety, Ticagrelor

Outcome Measures

Primary Outcomes (4)

• Description of the pharmacokinetic(PK) profile in terms of plasma concentration-time curve (AUC) of ticagrelor

  PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose

• Description of the pharmacokinetic(PK) profile in terms of AUC of the active metabolite of ticagrelor

  PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose

• Description of the pharmacokinetic(PK) profile in terms of maximum plasma concentration (Cmax) of ticagrelor

  PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose

• Description of the pharmacokinetic(PK) profile in terms of Cmax of the active metabolite of ticagrelor

  PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose

Secondary Outcomes (5)

• Description of the safety profile in terms of adverse events (AE)

  From first dose through to the follow-up visit.

• Description of the safety profile in terms of laboratory variables

  Safety labs at screening, Day -1, Day 3 (48 hours after treatment) and follow-up

• Description of the safety profile in terms of vital signs

  Vital signs at screening, pre-dose, 1 h, 3, 6, 12 and 24 hours post-dose, Day 3 for all treatment periods and follow-up

• Description of the safety profile in terms of physical examination findings

  Physical examination at screening, pre-dose, Day 3 and follow-up

• Description of the safety profile in terms of Electrocardiogram (ECG)

  ECGs at screening, Day 3 and follow-up

Study Arms (3)

A

EXPERIMENTAL

Ticagrelor 90 mg as a whole tablet

Drug: Ticagrelor 90 mg whole tablet

B

EXPERIMENTAL

Ticagrelor 90 mg tablet crushed and suspended in water

Drug: Ticagrelor 90 mg tablet crushed

C

EXPERIMENTAL

Dispersed ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the the stomach

Drug: Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube

Interventions

Ticagrelor 90 mg whole tablet DRUG

Ticagrelor 90 mg whole tablet administered as a single oral dose

A

Ticagrelor 90 mg tablet crushed DRUG

Ticagrelor 90 mg crushed and suspended in water

B

Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube DRUG

Dispersed 90 mg ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the stomach

C

Eligibility Criteria

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

You may qualify if:

• Healthy male and female volunteers aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venepuncture
• Have a body mass index between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg (110 pounds \[lbs\]) and no more than 100 kg (220 lbs).
• Provision of signed and dated, written informed consent prior to any study specific procedures

You may not qualify if:

• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
• History of haemophilia, von Willebrand's disease, lupus anticoagulant or other diseases/syndromes that can either alter or increase the propensity for bleeding
• A personal history of vascular abnormalities including aneurysms; a personal history of severe haemorrhage, haematemesis, melena, haemoptysis, severe epistaxis, severe thrombocytopenia, intracranial haemorrhage; or rectal bleeding within 3 months prior to the screeening visit; or history suggestive of peptic ulcer disease
• History of frequent and/or significant nose bleed or clinically significant non traumatic bleed, bruise/haematoma or any other clinically significant bleeding risk, as judged by the Investigator

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Interventions

Ticagrelor

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Judith Hsia, MD

  AstraZeneca, Wilmington, US

  STUDY DIRECTOR

• Mirjana Kujacic, MD

  AstraZeneca Mölndal, Sweden

  STUDY CHAIR

• Saeed Kahn, MBBS

  Quintiles London, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 27, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 18, 2013

Record last verified: 2013-09

Locations

GB (1)