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HealthyPhase 1NCT02191176

Study to Investigate Safety With Special Emphasis on ECG Effects and Tolerability After Oral Doses of Dextromethorphan Hydrobromide Monohydrate in Healthy Male and Female Subjects

A Phase 1 study testing Dextromethorphan syrup - low dose and Dextromethorphan syrup - high dose in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the current study is to investigate the safety with special emphasis on ECG effects, and tolerability of dextromethorphan hydrobromide monohydrate (2mg/mL syrup) in healthy male and female subjects following oral administration of 30 mg q.i.d. and 90 mg q.i.d. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Dextromethorphan syrup - low dose and Dextromethorphan syrup - high dose
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
No sites listed yet
Study dates
Jun 2009to Jul 2009
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, oral body temperature, vital signs (blood pressure, pulse rate), 12-lead Electrocardiogram (ECG), clinical laboratory tests
  • Age ≥18 and Age ≤55 years
  • BMI ≥18.5 and BMI ≤30 kg/m2 (Body Mass Index)
  • Extensive or poor metabolisers for CYP 2D6 based on the results of a genotyping test
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Who cannot join

  • Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of the gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells or blackouts
Show all 27Show fewer
  • Chronic or relevant acute infections
  • History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  • Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  • Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
  • Participation in another trial with an investigational drug within one month prior to first administration or during the trial
  • Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (more than 60 g/day)
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to first administration or during the trial)
  • Excessive physical activities (within one week prior to first administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of trial site
  • A marked baseline prolongation of QTc interval of >450 ms;
  • A history of additional risk factors for Torsades de points (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  • Use of drugs that inhibit or induce cytochrome P 450 enzymes, especially CYP2D6, within 30 days prior to first administration of the study medication or during the trial
  • For female subjects:
  • Pregnancy or planning to become pregnant within 2 months of study completion
  • Positive pregnancy test
  • No adequate contraception in woman of child bearing potential during the study, i.e., sterilisation, intrauterine device, injectables, oral contraceptive combined with a barrier method of contraception
  • Lactation period

About this study

Official title: A Phase I Multiple Dose Trial to Investigate Safety With Special Emphasis on ECG Effects and Tolerability After Oral Doses of 30 mg q.i.d. and 90 mg q.i.d. Dextromethorphan Hydrobromide Monohydrate (2 mg/mL Syrup) in Healthy Male and Female Subjects for 2 Days Followed by a Morning Dose (Extensive Metabolisers of CYP 2D6) and for 10 Days Followed by a Morning Dose (Poor Metabolisers of CYP 2D6) (Randomised, Double-blind, Placebo-controlled Groups)

The primary objective of the current study is to investigate the safety with special emphasis on ECG effects, and tolerability of dextromethorphan hydrobromide monohydrate (2mg/mL syrup) in healthy male and female subjects following oral administration of 30 mg q.i.d. and 90 mg q.i.d. for 2 days followed by a single morning dose (extensive metabolisers of CYP 2D6) and for 10 days followed by a single morning dose (poor metabolisers of CYP 2D6).

Additionally pharmacokinetic properties of dextromethorphan and its main metabolites dextrorphan, 3-hydroxymorphinan, and 3-methoxymorphinan will be investigated

Conditions
Healthy
Being tested
Dextromethorphan syrup - low dose, Dextromethorphan syrup - high dose, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dextromethorphan syrup - low doseDrug

  • Dextromethorphan syrup - high doseDrug

  • PlaceboDrug

Study groups in NCT02191176
Study groupRoleWhat they receive
Dextromethorphan syrup - low doseExperimentalNot described
Receives: Drug: Dextromethorphan syrup - low dose
Dextromethorphan syrup - high doseExperimentalNot described
Receives: Drug: Dextromethorphan syrup - high dose
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with abnormal findings in physical examination

    Measured: up to day 20

  2. Number of patients with clinically significant changes in vital signs (blood pressure and pulse rate)

    Measured: up to day 20

  3. Number of patients with clinically significant changes in 12-lead ECG (electrocardiogram) including QT interval and heart rate corrected QTcN, QTcF (Fridericia) and QTcB (Bazett)

    Measured: up to day 20

  4. Number of patients with abnormal changes in laboratory parameters

    Measured: up to day 20

  5. Assessment of tolerability by investigator on a 4-point scale

    Measured: day 20 (end of trial examination)

  6. Number of patients with adverse events

    Measured: up to 48 days

Secondary outcomes (13)

  1. Cmax (maximum measured concentration of the analyte in plasma) after the first dose

    Measured: within 5 hours after first drug administration

  2. tmax (time from dosing to the maximum concentration of the analyte in plasma) after the first dose

    Measured: within 5 hours after first drug administration

  3. AUCt1-t2 (area under the concentration-time curve of the analyte in plasma from the time interval t1 to t2) after the first dose

    Measured: within 5 hours after first drug administration

  4. AUC0-5 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 5 hours after administration) after the first dose

    Measured: within 5 hours after first drug administration

  5. Cmax,N (maximum measured concentration of the analyte in plasma following the Nth dose) after the last dose

    Measured: up to day 13

  6. tmax,N (time from last dosing to the maximum concentration of the analyte in plasma following the Nth dose) after the last dose

    Measured: up to day 13

  7. AUCt1-t2,N (area under the concentration-time curve of the analyte in plasma from the time interval t1 to t2 following the Nth dose) after the last dose

    Measured: up to day 13

  8. AUC0-5,N (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 5 hours following the Nth dose) after last dose

    Measured: up to day 13

  9. λz,N (terminal rate constant in plasma following the Nth dose) after the last dose

    Measured: up to day 13

  10. t1/2,N (terminal half-life of the analyte in plasma following the Nth dose) after the last dose

    Measured: up to day 13

  11. MRTpo,N (mean residence time of the analyte in the body after oral administration of the Nth dose) after the last dose

    Measured: up to day 13

  12. Cmax (maximum observed concentration of the analyte in plasma) after the second dose

    Measured: Day 1

  13. tmax (Time to Cmax of the analyte in plasma) after the second dose

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2014 (estimated)
  2. Study startJun 2009
  3. Primary completionJul 2009

Resources

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02191176
Sponsor's protocol ID
1134.3
Status last verified
Jul 2014
First submitted
15 Jul 2014
Last updated
16 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dextromethorphan syrup - low dose and Dextromethorphan syrup - high 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 5 inclusion and 27 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 16 Jul 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 patients with abnormal findings in physical examination (time frame: up to day 20). 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?

On the ClinicalTrials.gov record for NCT02191176.

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 16 Jul 2014.

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