Type 2 Diabetes MellitusPhase 1NCT01386541
Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers
A Phase 1 study testing BYK324677 in people with Type 2 Diabetes Mellitus, run by Nycomed at 1 site in Germany.
Trial summary
This monocenter trial is conducted to obtain first data on safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677 in humans. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- BYK324677
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Nov 2011
- 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
- Given written informed consent
- Healthy male and female subjects. Assessed as healthy based on a screening examination including medical history, physical examination, blood pressure (systolic ≤140 mmHg, diastolic ≤90 mmHg), pulse rate (within 45-95 bpm), ECG assessment, and clinical laboratory results
- Body mass index (BMI) between ≥18 and ≤28 kg/m², and a body weight ≥60 kg
Who cannot join
- History or current evidence of specified diseases
- History of malignancy in the past 5 years
- Gain or loss in body weight of more than 5% within the last 2 months or use of weight-loss medication within the last 3 months
- ECG abnormalities of clinical relevance
- Suspected hypersensitivity to the trial medication
- Positive virology tests indicating acute or chronic infections
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- Clinically relevant laboratory parameters outside a specified range
- Use of specified medications within certain time frames or use of certain co-medications
- Abuse of alcohol or drugs
- Dietary habits that would prevent from taking standardised meals
- Female subjects: positive pregnancy test; lack of medically reliable methods of contraception during the trial
- Donation of blood
- Smoking within the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Safety/Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Doses of BYK324677 in Healthy Volunteers. A Monocentre, Placebo-controlled, Cross-over, Double-blind, Randomised Trial
This monocenter trial is conducted to obtain first data on safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677 in humans. In addition, the trial should provide preliminary information on a possible influence of sex, food intake, and posology (once or twice daily administration of BYK324677) to support the further planning of the drug development programme.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- BYK324677
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BYK324677Drug
capsules, administered orally
| Study group | Role | What they receive |
|---|---|---|
| BYK324677 | Active comparator | * Dose group I: total daily dose 2 mg (1 mg BID or 2 mg SID)
* Dose group II: total daily dose 4 mg (2 mg BID or 4 mg SID)
* Dose group III: total daily dose 6 mg (3 mg BID or 6 mg SID)
In each dose group 12 subjects (8 subjects BYK324677, 4 subjects placebo) are planned.
Within each dose group, the subjects will be randomised to either BYK324677 or placebo at a ratio of 2:1.
Within each verum group, the subjects will be randomised to one of the 2 treatment sequences (BID/SID or SID/BID, ratio 1:1) and treated in a cross-over manner. Receives: Drug: BYK324677 |
| Placebo | Placebo comparator | Not described Receives: Drug: BYK324677 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety/tolerability of multiple dosing of BYK324677 given once daily (SID) or twice daily (BID) in healthy volunteers.
Safety/tolerability variables: adverse events (AEs), vital signs (BP, pulse rate, body temperature), 12-lead ECG (PQ [=PR], QRS, QT, QTcF and QTcB intervals, heart rate), laboratory parameters including urinalysis.
Measured: during screening, clinical part (treatment) and end-of-trial examination (up to 8 weeks)
Secondary outcomes (2)
Exploratory assessment of the pharmacokinetics (PK) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.
Pharmacokinetic variables (e.g. AUC, Cmax, tmax, t1/2) of BYK324677 on Day 1 and Day 5 (single dose i.e. after first Investigational medicinal product (IMP) dose vs steady state) as well as on Day 4 and Day 5 (fed vs fasted, respectively).
Measured: during Treatment Period 1 and Period 2 (up to 3 weeks)
Exploratory assessment of the pharmacodynamics (PD) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.
Pharmacodynamic variables glucose, insulin, glucagon-like peptide 1 and glucagon on Day -1, Day 4 (fed) and Day 5 (fasted).
Measured: during Treatment Period 1 and Period 2 (up to 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nycomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386541
- Sponsor's protocol ID
- B5-8012-101-RD
- Other IDs
- 2010-023857-12
- Status last verified
- May 2012
- First submitted
- 28 Jun 2011
- Last updated
- 7 May 2012
- Results posted
- 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
- Investigation of Safety/Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Doses of BYK324677 in Healthy Volunteers. A Monocentre, Placebo-controlled, Cross-over, Double-blind, Randomised Trial
- ClinicalTrials.gov ID
- NCT01386541
- Acronym / sponsor ID
- B5-8012-101-RD
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- NycomedIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Jul 2011 (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.
This monocenter trial is conducted to obtain first data on safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677 in humans. In addition, the trial should provide preliminary information on a possible influence of sex, food intake, and posology (once or twice daily administration of BYK324677) to support the further planning of the drug development programme.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BYK324677 | Active comparator | Drug: BYK324677* Dose group I: total daily dose 2 mg (1 mg BID or 2 mg SID) * Dose group II: total daily dose 4 mg (2 mg BID or 4 mg SID) * Dose group III: total daily dose 6 mg (3 mg BID or 6 mg SID) In each dose group 12 subjects (8 subjects BYK324677, 4 subjects placebo) are planned. Within each dose group, the subjects will be randomised to either BYK324677 or placebo at a ratio of 2:1. Within each verum group, the subjects will be randomised to one of the 2 treatment sequences (BID/SID or SID/BID, ratio 1:1) and treated in a cross-over manner. |
| Placebo | Placebo comparator | Drug: BYK324677 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Given written informed consent
- Healthy male and female subjects. Assessed as healthy based on a screening examination including medical history, physical examination, blood pressure (systolic ≤140 mmHg, diastolic ≤90 mmHg), pulse rate (within 45-95 bpm), ECG assessment, and clinical laboratory results
- Body mass index (BMI) between ≥18 and ≤28 kg/m², and a body weight ≥60 kg
Key exclusion criteria (13 listed)
- History or current evidence of specified diseases
- History of malignancy in the past 5 years
- Gain or loss in body weight of more than 5% within the last 2 months or use of weight-loss medication within the last 3 months
- ECG abnormalities of clinical relevance
- Suspected hypersensitivity to the trial medication
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 |
|---|---|---|
| BYK324677capsules, administered orally | Drug | BYK324677, Placebo |
Primary outcome
Assessment of the safety/tolerability of multiple dosing of BYK324677 given once daily (SID) or twice daily (BID) in healthy volunteers.
Time frame: during screening, clinical part (treatment) and end-of-trial examination (up to 8 weeks)
Safety/tolerability variables: adverse events (AEs), vital signs (BP, pulse rate, body temperature), 12-lead ECG (PQ [=PR], QRS, QT, QTcF and QTcB intervals, heart rate), laboratory parameters including urinalysis.
2 secondary outcomes
Exploratory assessment of the pharmacokinetics (PK) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.
Time frame: during Treatment Period 1 and Period 2 (up to 3 weeks)
Exploratory assessment of the pharmacodynamics (PD) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.
Time frame: during Treatment Period 1 and Period 2 (up to 3 weeks)
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.
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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.
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 BYK324677 in people with Type 2 Diabetes Mellitus, 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 3 inclusion and 13 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?
Assessment of the safety/tolerability of multiple dosing of BYK324677 given once daily (SID) or twice daily (BID) in healthy volunteers. (time frame: during screening, clinical part (treatment) and end-of-trial examination (up to 8 weeks)). 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.