Safety and Tolerability of EGT0001474 in Healthy VolunteersPhase 1NCT00854113
Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers
A Phase 1 study testing EGT0001474 in people with Safety and Tolerability of EGT0001474 in Healthy Volunteers, run by Theracos at 1 site in United States.
Trial summary
This study evaluated the safety, tolerability and pharmacokinetics of single or multiple doses of EGT0001474. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability of EGT0001474 in Healthy Volunteers
- What is being tested?
- EGT0001474
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female volunteers between the ages of 18 and 55 years inclusive.
- In good health.
- Female subjects must be surgically sterilized or postmenopausal.
- Body mass index (BMI) between 18 kg/m2 and 30 kg/m2 inclusive.
- Non-smoker.
- Negative drug and alcohol screens.
Who cannot join
- Abnormal ECG
- Sitting blood pressure above 140/90 mmHg on 2 evaluations at least 10 minutes apart at screening
- Treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
- Previous treatment with EGT0001474.
- History of drug abuse.
- Febrile illness within 5 days prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Phase I , Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of EGT0001474 In Healthy Volunteers
This study evaluated the safety, tolerability and pharmacokinetics of single or multiple doses of EGT0001474.
Read the detailed description
EGT0001474 is an inhibitor of human sodium dependent glucose co-transporter II being developed for the treatment of Type II Diabetes mellitus.
This is a singe center, Phase-1, double blinded,placebo controlled, dose escalation study of single and multiple ascending doses of EGT0001474 in healthy male and female subjects.
In part-1, subjects were randomized to receive single doses of EGT0001474 at 2.5-150 mg or placebo in the ratio of 3:1. In part-2, subjects were randomized to receive 14 daily doses of EGT0001474 at 10, 50 and 150 mg or placebo in the ratio of 4:1. When the various doses were analysed, the maximum dose 150 mg was found to be tolerable. Although there was no serious adverse events, mild adverse events were observed.
This study provided information on human safety, tolerability, PK and pharmacodynamic effects of EGT0001474.
- Being tested
- EGT0001474, Placebo
- Keywords
- Diabetes Mellitus Type 2
- 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.
EGT0001474Drug
Also called Human SGLT2 inhibitor
Oral ascending doses given daily as capsules for up to 14 days
PlaceboDrug
Also called Human SGLT2 inhibitor
Placebo to match EGT0001474
| Study group | Role | What they receive |
|---|---|---|
| EGT0001474 | Experimental | Ascending doses of EGT0001474 Receives: Drug: EGT0001474 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetics results. Cmax -Maximum plasma drug concentration
Measured: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Tmax
Pharmacokinetics results. Time to maximum plasma drug concentration (Tmax) was calculated for each groups
Measured: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
AUC 0-t
Pharmacokinetics results. AUC 0-t - Are under plasma concentration-time curve from time 0 time t.
Measured: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
t1/2
Pharmacokinetics results.t 1/2 - apparent terminal half life
Measured: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
AUC 0 -24
Pharmacokinetics results. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose.
Measured: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Terminal Rate Constant.
Pharmacokinetics results. Terminal rate constant was estimated by linear regression of logarithmic transformed concentration versus time data
Measured: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
CL/F
Pharmacokinetics results. Apparent oral clearance
Measured: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
VZ/F
Pharmacokinetic results. Apparent volume of distribution
Measured: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Safety and Tolerability of EGT0001474 in Healthy VolunteersStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theracos
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mason W. Freeman, M.D., Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854113
- Sponsor's protocol ID
- THR-1474-C-328
- Status last verified
- Jun 2019
- First submitted
- 27 Feb 2009
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I , Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of EGT0001474 In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00854113
- Acronym / sponsor ID
- THR-1474-C-328
- Keywords
- Diabetes Mellitus Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- TheracosIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Posted 12 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the safety, tolerability and pharmacokinetics of single or multiple doses of EGT0001474.
Detailed description
EGT0001474 is an inhibitor of human sodium dependent glucose co-transporter II being developed for the treatment of Type II Diabetes mellitus.
This is a singe center, Phase-1, double blinded,placebo controlled, dose escalation study of single and multiple ascending doses of EGT0001474 in healthy male and female subjects.
In part-1, subjects were randomized to receive single doses of EGT0001474 at 2.5-150 mg or placebo in the ratio of 3:1. In part-2, subjects were randomized to receive 14 daily doses of EGT0001474 at 10, 50 and 150 mg or placebo in the ratio of 4:1. When the various doses were analysed, the maximum dose 150 mg was found to be tolerable. Although there was no serious adverse events, mild adverse events were observed.
This study provided information on human safety, tolerability, PK and pharmacodynamic effects of EGT0001474.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGT0001474 | Experimental | Drug: EGT0001474Ascending doses of EGT0001474 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female volunteers between the ages of 18 and 55 years inclusive.
- In good health.
- Female subjects must be surgically sterilized or postmenopausal.
- Body mass index (BMI) between 18 kg/m2 and 30 kg/m2 inclusive.
- Non-smoker.
Key exclusion criteria (6 listed)
- Abnormal ECG
- Sitting blood pressure above 140/90 mmHg on 2 evaluations at least 10 minutes apart at screening
- Treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
- Previous treatment with EGT0001474.
- History of drug abuse.
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 |
|---|---|---|
| EGT0001474Also: Human SGLT2 inhibitorOral ascending doses given daily as capsules for up to 14 days | Drug | EGT0001474 |
| PlaceboAlso: Human SGLT2 inhibitorPlacebo to match EGT0001474 | Drug | Placebo |
Primary outcome
Cmax
Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetics results. Cmax -Maximum plasma drug concentration
Tmax
Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetics results. Time to maximum plasma drug concentration (Tmax) was calculated for each groups
AUC 0-t
Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetics results. AUC 0-t - Are under plasma concentration-time curve from time 0 time t.
t1/2
Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetics results.t 1/2 - apparent terminal half life
AUC 0 -24
Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetics results. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose.
Terminal Rate Constant.
Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetics results. Terminal rate constant was estimated by linear regression of logarithmic transformed concentration versus time data
CL/F
Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetics results. Apparent oral clearance
VZ/F
Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetic results. Apparent volume of distribution
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Mason W. Freeman, M.D. study chair
Massachusetts General Hospital
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 EGT0001474 in people with Safety and Tolerability of EGT0001474 in Healthy Volunteers, run by Theracos at 1 site in United States.
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 6 inclusion and 6 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 6 Jun 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax (time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days). The study lists 8 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 6 Jun 2019.