Tolerability of Asasantin in Healthy Female and Male Subjects

NCT02269228 | Completed Phase 1

• 1 other identifier: 9.131
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the occurrence of dipyridamole associated headaches in healthy subjects using a titration scheme or not

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Cumulated headache (intensity x duration) per day based on mean severity per waking hours expressed as area under the curve (AUC)

  Day 14 after first drug administration

Secondary Outcomes (9)

• Proportion of subjects experiencing moderate/severe headache

  Day 14 after first drug administration

• Proportion of subjects experiencing headache

  Day 14 after first drug administration

• Cumulated headache (intensity x duration) per day based on maximum severity per day expressed as AUC

  Day 14 after first drug administration

• Amount of acetylsalicylic acid (ASA) 500 used to cut headache

  Day 14 after first drug administration

• Changes from baseline in vital signs

  Pre-dose and day 17 after first drug administration

Study Arms (3)

Asasantin ER

EXPERIMENTAL

Administered once daily (days 1 to 7), followed by twice daily administration (days 8 to 14)

Drug: Asasantin ER

Asasantin ER, administered twice daily from day 1 to day 14

EXPERIMENTAL

Drug: Asasantin ER

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Asasantin ER DRUG

Asasantin ER; Asasantin ER, administered twice daily from day 1 to day 14

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All participants in the study should be healthy females/males, range from 18 to 55 years of age and be within a Broca Index of ≥ - 20 % and ≤ + 20 %
• Prior to admission to the study all subjects will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent.

You may not qualify if:

• Subjects will be excluded from the study if the results of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and are of clinical relevance
• Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
• Subjects with known history of orthostatic hypotension, fainting spells or blackouts
• Subjects with chronic or relevant acute infections
• Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Subjects who have taken a drug with a long half-life (\> 24 hours) (≤ 1 month prior to administration or during the trial)
• Subjects who received any other drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
• Subjects who have participated in another study with an investigational drug (≤ 1 month prior to administration or during the trial)
• Subjects who smoke more than 15 cigarettes or 4 cigars or 4 pipes/day
• Subjects who are not able to refrain from excessive consumption of methylxanthine containing drinks or food
• Subjects who drink more than 60 g of alcohol per day
• Subjects who are dependent on drugs
• Subjects who have donated blood (\> 400 ml) (≤ 4 weeks prior to administration or during the trial)
• Subjects who have participated in excessive physical activities (≤ 5 days prior to administration or during the 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: October 20, 2014
• First Posted: October 21, 2014
• Study Start: February 1, 2000
• Primary Completion: April 1, 2000
• Last Updated: October 21, 2014

Record last verified: 2014-10