HealthyPhase 1NCT01028924
Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers
A Phase 1 study testing Teduglutide in people with Healthy, run by Nycomed at 1 site in Germany.
Trial summary
The primary objective of this trial is to investigate if teduglutide has an effect on cardiac repolarisation (QT, QTc interval). Secondary objectives are the investigation of possible effects on heart rate and cardiac conduction (RR and PR intervals, QRS duration), pharmacokinetics and safety and tolerability in… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Healthy
- What is being tested?
- Teduglutide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Apr 2010
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy male or female volunteers
- Normal body weight (body mass index within ≥18 and 29 kg/m2 (inclusive) and a body weight >50 kg (females) and >60 kg (males).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, 4-period, Placebo and Active-controlled, Single-dose, Change-over Trial to Evaluate the Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers
The primary objective of this trial is to investigate if teduglutide has an effect on cardiac repolarisation (QT, QTc interval). Secondary objectives are the investigation of possible effects on heart rate and cardiac conduction (RR and PR intervals, QRS duration), pharmacokinetics and safety and tolerability in healthy subjects, and to determine the effect of the positive control, moxifloxacin, for sensitivity analysis. The trial will consist of a screening and a treatment phase of four treatment periods. There is a washout period of at least 7 days and 4 weeks at maximum between administrations. The expected total trial duration for the individual subject will be about 7 weeks (maximum 17) weeks.
- Conditions
- Healthy
- Being tested
- Teduglutide
- Keywords
- Thorough QTc-Study, Short Bowel Syndrome, Cardiac safety
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeduglutideDrug
subcutaneous (SC), single dose
| Study group | Role | What they receive |
|---|---|---|
| Teduglutide 5 mg | Experimental | Treatment A, subcutaneous injection Receives: Drug: Teduglutide |
| Teduglutide 20 mg | Experimental | Treatment B, subcutaneous injection Receives: Drug: Teduglutide |
| Placebo | Placebo comparator | subcutaneous injection Receives: Drug: Teduglutide |
| Moxifloxacin | Active comparator | 400 mg, oral Receives: Drug: Teduglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG measurement/assessment to determine the effect of a single dose of teduglutide on cardiac repolarisation (QT, QTc interval).
Measured: until 24 h post dose
Secondary outcomes (5)
ECG measurement/assessment to determine the effect of a single dose of a positive control, moxifloxacin, on cardiac repolarisation, heart rate, and conduction
Measured: until 24 h post dose
ECG measurement/assessment to determine the effect of a single dose of teduglutide on heart rate and cardiac conduction (RR and PR intervals, QRS duration)
Measured: until 24 h post dose
PK blood samples to investigate pharmacokinetics of teduglutide in plasma
Measured: until 24 h post dose
PK blood samples to explore the concentration effect relationship on QT/QTc intervals
Measured: until 24 h post dose
ECG measurement/assessment and PK blood samples to investigate safety and tolerability of teduglutide
Measured: within 14 days after trial medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2010
- Study completionApr 2010
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.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nycomed
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028924
- Sponsor's protocol ID
- TE-1777-102-EC
- Status last verified
- Apr 2010
- First submitted
- 8 Dec 2009
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, 4-period, Placebo and Active-controlled, Single-dose, Change-over Trial to Evaluate the Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT01028924
- Acronym / sponsor ID
- TE-1777-102-EC
- Conditions
- Healthy
- Keywords
- Thorough QTc-Study, Short Bowel Syndrome, Cardiac safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- NycomedIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 9 Dec 2009 (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 primary objective of this trial is to investigate if teduglutide has an effect on cardiac repolarisation (QT, QTc interval). Secondary objectives are the investigation of possible effects on heart rate and cardiac conduction (RR and PR intervals, QRS duration), pharmacokinetics and safety and tolerability in healthy subjects, and to determine the effect of the positive control, moxifloxacin, for sensitivity analysis. The trial will consist of a screening and a treatment phase of four treatment periods. There is a washout period of at least 7 days and 4 weeks at maximum between administrations. The expected total trial duration for the individual subject will be about 7 weeks (maximum 17) weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Teduglutide 5 mg | Experimental | Drug: TeduglutideTreatment A, subcutaneous injection |
| Teduglutide 20 mg | Experimental | Drug: TeduglutideTreatment B, subcutaneous injection |
| Placebo | Placebo comparator | Drug: Teduglutidesubcutaneous injection |
| Moxifloxacin | Active comparator | Drug: Teduglutide400 mg, oral |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or female volunteers
- Normal body weight (body mass index within ≥18 and 29 kg/m2 (inclusive) and a body weight >50 kg (females) and >60 kg (males).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Teduglutidesubcutaneous (SC), single dose | Drug | Moxifloxacin, Placebo, Teduglutide 20 mg, Teduglutide 5 mg |
Primary outcome
ECG measurement/assessment to determine the effect of a single dose of teduglutide on cardiac repolarisation (QT, QTc interval).
Time frame: until 24 h post dose
5 secondary outcomes
ECG measurement/assessment to determine the effect of a single dose of a positive control, moxifloxacin, on cardiac repolarisation, heart rate, and conduction
Time frame: until 24 h post dose
ECG measurement/assessment to determine the effect of a single dose of teduglutide on heart rate and cardiac conduction (RR and PR intervals, QRS duration)
Time frame: until 24 h post dose
PK blood samples to investigate pharmacokinetics of teduglutide in plasma
Time frame: until 24 h post dose
PK blood samples to explore the concentration effect relationship on QT/QTc intervals
Time frame: until 24 h post dose
ECG measurement/assessment and PK blood samples to investigate safety and tolerability of teduglutide
Time frame: within 14 days after trial medication 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 7 May 2012.
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.
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 Teduglutide in people with Healthy, run by Nycomed at 1 site in Germany.
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 2 inclusion and 0 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 7 May 2012. 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 Germany. 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 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?
ECG measurement/assessment to determine the effect of a single dose of teduglutide on cardiac repolarisation (QT, QTc interval). (time frame: until 24 h post dose). 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 7 May 2012.