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Trial record 31 of 449 for:    diphenhydramine

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

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ClinicalTrials.gov Identifier: NCT01965301
Recruitment Status : Terminated
First Posted : October 18, 2013
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Bioprojet

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

Condition or disease Intervention/treatment Phase
Healthy Male Volunteers Drug: BP1.5375 suspension Drug: Diphenhydramine Drug: Placebo Phase 1

Detailed Description:
This is a single center, Double-blind, placebo controlled, randomized study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of BP1.5375 after single oral administrations ranging in healthy male subjects (Part 1) followed by the assessment of the effect of 3 single different BP1.5375 oral doses on polysomnography in comparison to 50 mg diphenhydramine and placebo in healthy male subjects (Part 2).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Double-blind, Placebo Controlled, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375 After Single Oral Administrations Ranging From 0.5 mg to 100 mg in Healthy Male Subjects (Part 1) Followed by the Assessment of the Effect of 3 Single Different BP1.5375 Oral Doses on Polysomnography in Comparison to 50 mg Diphenhydramine and Placebo in Healthy Male Subjects (Part 2).
Study Start Date : October 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: BP1.5375
Single oral administration ranging from 0.5 mg to 100 mg
Drug: BP1.5375 suspension
single oral dose

Drug: Diphenhydramine
single oral dose of Diphenhydramine 50mg

Drug: Placebo
Single oral dose

Active Comparator: Diphenhydramine
Single oral dose of diphenhydramine 50mg
Drug: BP1.5375 suspension
single oral dose

Drug: Diphenhydramine
single oral dose of Diphenhydramine 50mg

Drug: Placebo
Single oral dose

Placebo Comparator: Placebo
Single oral dose
Drug: BP1.5375 suspension
single oral dose

Drug: Diphenhydramine
single oral dose of Diphenhydramine 50mg

Drug: Placebo
Single oral dose




Primary Outcome Measures :
  1. Single Ascending Dose - safety and tolerability (Part 1) [ Time Frame: Study period and follow up visit will be no more than 5 weeks ]

    To determine the clinical and biological safety and tolerability of BP1.5375 after an oral increasing single dose administration BP1.5375.

    • Physical examination : at screening and Follow-Up; a directed physical examination pre-dose and 24 hours post-dose,
    • Vital signs : at screening, on day -2, on day 1 pre-dose then 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours post dose and FU,
    • Body temperature : at screening, on day -2, on day 1 pre-dose, then 24 hours post-dose and FU,
    • Standard 12 lead ECG recording : at screening, on day -2, on day 1 pre-dose, then 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose and FU,
    • Clinical laboratory tests: at screening, on day1 pre-dose, then 24 hours post-dose and FU,
    • 48-hour 12 leads continuous ECG Holter recording from day -1 morning until dosing and from dosing until the morning of day 2.

  2. Proof of Concept - effect on polysomnography (Part 2) [ Time Frame: Study period and follow up visit will be no more than 9 weeks ]

    To determine whether an BP1.5375 single oral dose induced an effect on polysomnography in healthy male subjects compared to diphenhydramine 50 mg and matching placebo.

    Safety and tolerability :

    Monitoring for the occurrence of AEs, changes in physical examination, vital signs (body temperature, lying and standing blood pressure and heart rate), ECG, and clinical laboratory tests. Assessments will be performed at the following time points :

    • Physical examination: at screening, on days 1 and FU,
    • Vital signs: at screening, on days 1 and 2 and FU,
    • Body temperature: at screening and FU,
    • Standard 12 lead ECG recording : at screening, on days 1 and 2 morning and FU,
    • Clinical laboratory tests : at screening, on days 1 and 2 and FU.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965301


Locations
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Netherlands
Centre for Human Drug Research
Leiden, Netherlands, 2333
Sponsors and Collaborators
Bioprojet
Investigators
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Principal Investigator: van Gerven Joop, MD Centre for Human Drug Research

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Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01965301     History of Changes
Other Study ID Numbers: P12-03/BP1.5375
2013-000697-30 ( EudraCT Number )
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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Diphenhydramine
Promethazine
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Antipruritics
Dermatologic Agents