HealthyPhase 1NCT02199873
Safety, Tolerability and Pharmacodynamics of BIIX 1 XX in Healthy Young Male Volunteers
A Phase 1 study testing BIIX 1 XX - single rising dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of the present study is to obtain information about the safety and tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a methacholine challenge test and to obtain preliminary pharmacokinetic data Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIIX 1 XX - single rising dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 1998to Sep 1998
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers who have Broca-Indices within +-20%
- Participants in the age range between 21 to 50 years
- Following the methacholine challenge the airway resistance (Raw) shows an increase of at least 130%
- In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give his written informed consent prior to admission to the study
- As part of the screening (within 14 days before drug administration), each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead Electrocardiogram (ECG)
- Haematopoietic, hepatic and renal function test will be carried out in the laboratory
- The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
Who cannot join
- Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 15Show fewer
- Intake of a drug with a long half-life (>= 24 hours) within one month before enrolment in the study
- Use of any drugs which might influence the results of the trial the week previous to the start of the study
- Participation in another study with an investigational drug within the last two months preceding this study
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on study days
- Alcohol abuse (> 60g/day)
- Drug abuse
- Blood donation within the last 4 weeks
- Excessive physical activities within the last week before the study
About this study
Official title: A Single Increasing Dose Safety, Tolerability and Pharmacodynamics (Methacholine Challenge) Study After Inhalational Administration of BIIX 1 XX (Single Doses: 5 - 800 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)
The objective of the present study is to obtain information about the safety and tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a methacholine challenge test and to obtain preliminary pharmacokinetic data
- Conditions
- Healthy
- Being tested
- BIIX 1 XX - single rising dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIX 1 XX - single rising doseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIIX 1 XX - single rising dose | Experimental | Not described Receives: Drug: BIIX 1 XX - single rising dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: up to 3 months
Number of subjects with abnormal changes in laboratory parameters
Measured: up to 8 days after last drug administration
Change in impedance cardiography
Measured: up to 30 minutes after drug administration
Change in cutaneous microcirculation
Measured: up to 30 minutes after drug administration
Secondary outcomes (9)
Change in airway resistance (Raw) after methacholine challenge
Measured: up to 30 minutes after drug administration
Change in specific conductance (sGaw) after methacholine challenge
Measured: up to 30 minutes after drug administration
AUC (Area under the concentration-time curve of the analyte in plasma)
Measured: up to 168 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Measured: up to 168 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 168 hours after drug administration
Ae (Amount of analyte that is eliminated in urine)
Measured: up to 48 hours after drug administration
MRT (Mean residence time of the analyte in the body)
Measured: up to 168 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Measured: up to 168 hours after drug administration
CL/F(Apparent clearance of the analyte in plasma following extravascular administration)
Measured: up to 168 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJun 1998
- Primary completionSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199873
- Sponsor's protocol ID
- 1150.1
- Status last verified
- Oct 2014
- First submitted
- 24 Jul 2014
- Last updated
- 29 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Increasing Dose Safety, Tolerability and Pharmacodynamics (Methacholine Challenge) Study After Inhalational Administration of BIIX 1 XX (Single Doses: 5 - 800 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)
- ClinicalTrials.gov ID
- NCT02199873
- Acronym / sponsor ID
- 1150.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 1998
- Primary completion
- Sep 1998 (actual)
- First posted
- 25 Jul 2014 (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.
The objective of the present study is to obtain information about the safety and tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a methacholine challenge test and to obtain preliminary pharmacokinetic data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIX 1 XX - single rising dose | Experimental | Drug: BIIX 1 XX - single rising dose |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male volunteers who have Broca-Indices within +-20%
- Participants in the age range between 21 to 50 years
- Following the methacholine challenge the airway resistance (Raw) shows an increase of at least 130%
- In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give his written informed consent prior to admission to the study
- As part of the screening (within 14 days before drug administration), each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead Electrocardiogram (ECG)
Key exclusion criteria (15 listed)
- Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
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 |
|---|---|---|
| BIIX 1 XX - single rising dose | Drug | BIIX 1 XX - single rising dose |
| Placebo | Drug | Placebo |
Primary outcome
Number of subjects with adverse events
Time frame: up to 3 months
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 8 days after last drug administration
Change in impedance cardiography
Time frame: up to 30 minutes after drug administration
Change in cutaneous microcirculation
Time frame: up to 30 minutes after drug administration
9 secondary outcomes
Change in airway resistance (Raw) after methacholine challenge
Time frame: up to 30 minutes after drug administration
Change in specific conductance (sGaw) after methacholine challenge
Time frame: up to 30 minutes after drug administration
AUC (Area under the concentration-time curve of the analyte in plasma)
Time frame: up to 168 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 168 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 168 hours after drug administration
Ae (Amount of analyte that is eliminated in urine)
Time frame: up to 48 hours after drug administration
MRT (Mean residence time of the analyte in the body)
Time frame: up to 168 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 168 hours after drug administration
CL/F(Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 168 hours after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIX 1 XX - single rising dose in people with Healthy, run by Boehringer Ingelheim.
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 7 inclusion and 15 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: finished, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects with adverse events (time frame: up to 3 months). The study lists 4 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 29 Oct 2014.