First-time-in-man, to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

Phase I Single Ascending Dose (Part 1), phase IIa Proof Of Concept (Part 2)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bioprojet
• Treatments: Diphenhydramine; Promethazine

Criteria

Inclusion Criteria:

• Signed informed consent prior to any study-mandated procedure.

• Healthy male subjects aged between 18 and 45 years (inclusive).

• Subjects with a body weight of at least 50 kg and a body mass index (BMI) between 18.0 and 28.0 kg/m2 (both inclusive).

• Healthy subjects, based on history, physical examination, complete laboratory evaluation, and 12-lead ECG.

• Normal arterial blood pressure (BP) and pulse rate or, if abnormal, considered not clinically significant by the investigator. Normal BP to be [100-140] mmHg systolic and [45-90] mmHg diastolic. Normal pulse rate to be [40-90] bpm after 5 minutes rest in lying position.

Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.

Exclusion Criteria:

• Subject with a history of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurological, psychiatric, systemic, or infectious disease, or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject, or impact the validity of the study results.

• Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.

• Haematology, clinical chemistry, and urinalysis results deviating from the normal range to a clinically relevant extent at screening.

• Clinically significant findings on physical examination at screening.

• 12-lead electrocardiogram (ECG) with clinically relevant abnormalities in supine position at screening.

• Positive results from urine drug screen at screening.

• Veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access or puncture, or veins with a tendency for rupture during or after puncture).

• Treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort) within 2 weeks prior to the (first) scheduled administration of study drug, except paracetamol (maximum 1 g/day).

• Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening.

• History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.

• History or clinical evidence of any disease, and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs.

• Have undergone surgery or have donated an amount equal or more than 500 mL blood, or 300 mL of plasma, within 3 months prior to screening.

• Positive results from any of the hepatitis serology tests (HBsAg, anti-HCV), at screening.

• Positive results from the HIV 1 or/and 2 serology at screening.

• History of allergy to diphenhydramine or antihistaminic drugs.

• Smoking more than 5 cigarettes per day.