Healthy Male VolunteersPhase 1NCT01965301
First-time-in-man, to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375
A Phase 1 study testing BP1.5375 suspension and Diphenhydramine in people with Healthy Male Volunteers, run by Bioprojet at 1 site in Netherlands.
Trial summary
Phase I Single Ascending Dose (Part 1), phase IIa Proof Of Concept (Part 2) Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- BP1.5375 suspension and Diphenhydramine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Phase I Single Ascending Dose (Part 1), phase IIa Proof Of Concept (Part 2)
Read the 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).
- Conditions
- Healthy Male Volunteers
- Being tested
- BP1.5375 suspension, Diphenhydramine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP1.5375 suspensionDrug
single oral dose
DiphenhydramineDrug
single oral dose of Diphenhydramine 50mg
PlaceboDrug
Single oral dose
| Study group | Role | What they receive |
|---|---|---|
| BP1.5375 | Experimental | Single oral administration ranging from 0.5 mg to 100 mg Receives: Drug: BP1.5375 suspension; Drug: Diphenhydramine; Drug: Placebo |
| Diphenhydramine | Active comparator | Single oral dose of diphenhydramine 50mg Receives: Drug: BP1.5375 suspension; Drug: Diphenhydramine; Drug: Placebo |
| Placebo | Placebo comparator | Single oral dose Receives: Drug: BP1.5375 suspension; Drug: Diphenhydramine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Ascending Dose - safety and tolerability (Part 1)
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.
Measured: Study period and follow up visit will be no more than 5 weeks
Proof of Concept - effect on polysomnography (Part 2)
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.
Measured: Study period and follow up visit will be no more than 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startOct 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- van Gerven Joop, MD, Principal investigator, Centre for Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965301
- Sponsor's protocol ID
- P12-03/BP1.5375
- Other IDs
- 2013-000697-30
- Status last verified
- Jan 2015
- First submitted
- 11 Oct 2013
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT01965301
- Acronym / sponsor ID
- P12-03/BP1.5375
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 48 participants (actual)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I Single Ascending Dose (Part 1), phase IIa Proof Of Concept (Part 2)
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).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BP1.5375 | Experimental | Drug: BP1.5375 suspension, Drug: Diphenhydramine, Drug: PlaceboSingle oral administration ranging from 0.5 mg to 100 mg |
| Diphenhydramine | Active comparator | Drug: BP1.5375 suspension, Drug: Diphenhydramine, Drug: PlaceboSingle oral dose of diphenhydramine 50mg |
| Placebo | Placebo comparator | Drug: BP1.5375 suspension, Drug: Diphenhydramine, Drug: PlaceboSingle oral dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BP1.5375 suspensionsingle oral dose | Drug | BP1.5375, Diphenhydramine, Placebo |
| Diphenhydraminesingle oral dose of Diphenhydramine 50mg | Drug | BP1.5375, Diphenhydramine, Placebo |
| PlaceboSingle oral dose | Drug | BP1.5375, Diphenhydramine, Placebo |
Primary outcome
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.
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
van Gerven Joop, MD principal investigator
Centre for Human Drug Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BP1.5375 suspension and Diphenhydramine in people with Healthy Male Volunteers, run by Bioprojet at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Ascending Dose - safety and tolerability (Part 1) (time frame: Study period and follow up visit will be no more than 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.