HealthyPhase 1NCT02260076
Safety of Total Daily Doses of Polyethylene Glycol (PEG) 400 Administered Orally to Healthy Male Human Subjects
A Phase 1 study testing PEG 400 in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PEG 400
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Mar 2002
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- Age ≥ 18 and ≤ 55 years
- Broca ≥ - 20 % and ≤ + 20 %
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram [ECG]) deviating from normal and of clinical relevance
- History of current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
- History of orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- 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 drugs with a long half-life (> 24 hours) within one month prior to administration
- Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within one month prior to administration or during the trial
- Smoker (> 10 cigarettes or three cigars or three pipes/day) or inability to refrain from smoking 10 hours before the morning dose and one hour before afternoon/evening dose and one hour after any dose
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation within one month prior to administration or during the trial
- Excessive physical activities within five days prior to administration or during the trial
- Any laboratory value outside the clinically accepted reference range and of clinical relevance
About this study
Official title: Safety of Total Daily Doses of 5, 10, 15 and 20 mL PEG 400 Administered Orally to Healthy Male Human Subjects Once (QD) or Twice (BID) for 14 Days. A Single Center, Multiple Rising Dose Study, Placebo Controlled, Double-blinded at Each Dose Level
To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses
- Conditions
- Healthy
- Being tested
- PEG 400, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG 400Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| PEG 400 | Experimental | multiple rising doses Receives: Drug: PEG 400 |
| 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 clinically relevant findings in vital signs
blood pressure, pulse rate
Measured: up to 7 days after last drug administration
Number of subjects with clinically relevant findings in laboratory tests
Measured: up to 7 days after last drug administration
Number of subjects with clinically relevant findings in 12-lead ECG
Measured: up to 7 days after last drug administration
Number of subjects with clinically relevant findings in physical examination
Measured: up to 7 days after last drug administration
Number of subjects with adverse events
Measured: up to 7 days after last drug administration
Assessment of global tolerability by the investigator on a 4-point rating scale
Measured: up to 7 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startSep 2001
- Primary completionMar 2002
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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 64 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
- NCT02260076
- Sponsor's protocol ID
- 352.2030
- Status last verified
- Oct 2014
- First submitted
- 8 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Total Daily Doses of 5, 10, 15 and 20 mL PEG 400 Administered Orally to Healthy Male Human Subjects Once (QD) or Twice (BID) for 14 Days. A Single Center, Multiple Rising Dose Study, Placebo Controlled, Double-blinded at Each Dose Level
- ClinicalTrials.gov ID
- NCT02260076
- Acronym / sponsor ID
- 352.2030
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Mar 2002 (actual)
- First posted
- 9 Oct 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.
To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG 400 | Experimental | Drug: PEG 400multiple rising doses |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- Age ≥ 18 and ≤ 55 years
- Broca ≥ - 20 % and ≤ + 20 %
Key exclusion criteria (15 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram [ECG]) deviating from normal and of clinical relevance
- History of current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
- History of orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- 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 |
|---|---|---|
| PEG 400 | Drug | PEG 400 |
| Placebo | Drug | Placebo |
Primary outcome
Number of subjects with clinically relevant findings in vital signs
Time frame: up to 7 days after last drug administration
blood pressure, pulse rate
Number of subjects with clinically relevant findings in laboratory tests
Time frame: up to 7 days after last drug administration
Number of subjects with clinically relevant findings in 12-lead ECG
Time frame: up to 7 days after last drug administration
Number of subjects with clinically relevant findings in physical examination
Time frame: up to 7 days after last drug administration
Number of subjects with adverse events
Time frame: up to 7 days after last drug administration
Assessment of global tolerability by the investigator on a 4-point rating scale
Time frame: up to 7 days after last 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 9 Oct 2014.
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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.
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 PEG 400 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 4 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 9 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 clinically relevant findings in vital signs (time frame: up to 7 days after last drug administration). The study lists 6 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 9 Oct 2014.