DiabetesPhase 1NCT01472809
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral ZYGK1 in Healthy Volunteers
A Phase 1 study testing ZYGK1 in people with Diabetes, run by Zydus Lifesciences Limited at 1 site in India.
Trial summary
The purpose of this study is to determine (1) whether ZYGK1 is safe and well tolerated, (2) the pharmacokinetics (what body does to ZYGK1) and (3) pharmacodynamics (what drugs does to the body) in the healthy and diabetic subject. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- ZYGK1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2011to Dec 2012
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-45 years
- Mentally, physically, and legally eligible to give informed consent
- Male and female volunteers weighing between 50-75 kg and 45-75 kg (4) respectively.
- Ability to communicate effectively with the study personnel
- Willingness to adhere to the protocol requirements
- For gender effect study, only females with history of sterility or at least one year menopause or use of long acting nonhormonal contraceptive measures (e.g., intrauterine device) will be recruited.
- At least one panel, in single ascending dose and multiple ascending dose will include subjects with type 2 diabetes as defined by American Diabetes Association
Who cannot join
- Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYGK1 formulation
- Presence or history of pancreatitis at any time (Serum Amylase/Serum Lipase more than upper normal limit (UNL))
- Presence or history of severe gastrointestinal disease in the last 6 months
- Presence or history of renal insufficiency at any time (serum creatinine >UNL)
- Active liver disease and/or liver transaminases greater than 1.5 X UNL
- History or presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement)
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- Abnormal bleeding time (BT), clotting time (CT), prothrombin time (PT), and activated partial prothrombin time (APTT)
- History or presence of any medication in the last 14 days
- History or presence of significant alcoholism or drug abuse within the past 1 year
- History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day)
- Difficulty with donating blood
- Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg
- Pulse rate less than 60 minute and more than 100/minute
- Any clinically significant laboratory findings during screening
- History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening
- Major illness and/or major surgery in last 3 months
- Volunteers who have participated in any drug research study other than the present trial within past 3 months
- Volunteers who have donated one unit (350 ml) of blood in the past 3 months
Trial locations and contacts
1 site in 1 country.
India1 site
Clinical R&D, Zydus Research Center, Cadila Healthcare Limited, NH No.8, Moraiya
Ahmedabad, Gujarat, 382213
About this study
Official title: A Randomized, Double Blind Placebo Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZYGK1, a Novel Glucokinase Activator, Following Oral Administration in Healthy Volunteers
The purpose of this study is to determine (1) whether ZYGK1 is safe and well tolerated, (2) the pharmacokinetics (what body does to ZYGK1) and (3) pharmacodynamics (what drugs does to the body) in the healthy and diabetic subject.
Read the detailed description
This study will be a randomized, double blind, placebo controlled study and is divided into four plans:
- Plan I: Single Ascending Dose (SAD) Study
- Plan II: Multiple Ascending Dose (MAD)Study
- Plan III: Gender Effect study
- Plan IV: Food Effect study
First Plan I, Plan III and Plan IV will be conducted in healthy volunteers. After reviewing the results, decision shall be taken whether the multiple ascending doses shall be studied in healthy human volunteers or in subjects with type 2 diabetes.
- Conditions
- Diabetes
- Being tested
- ZYGK1, Placebo
- Keywords
- ZYGK1, Cadila, Zydus, ZRC, Zydus Research Center, Phase 1, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZYGK1Drug
ZYGK1 Tablets: 0.125, 0.25, 0.5, 1, 2, .... mg.
Dose escalation will continue till single AE occurs in any block of 3 volunteers on ZYGK1 or pharmacokinetic (dose linearity) saturation is reached or desired PK/PD effect is achieved
PlaceboDrug
Placebo Tablets: 0.125, 0.25, 0.5, 1, 2, ... mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo tablets Receives: Drug: Placebo |
| ZYGK1 | Experimental | ZYGK1 tablets; 0.125, 0.25, 0.5, 1, 2, ... mg.
Dose escalation will continue till single AE occurs in any block of 3 volunteers on ZYGK1 or pharmacokinetic (dose linearity) saturation is reached or desired PK/PD effect is achieved Receives: Drug: ZYGK1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Safety and tolerability for-
- Plan I, Plan III and Plan IV [Time frame: up to Day 8]
- Plan II [Time frame: upto Day 14]
Frequency of adverse events will be assessed at each dose level.
Measured: Upto 14 Days
Secondary outcomes (2)
Pharmacokinetics
Pharmacokinetics after oral administration of ZYGK1 in
- Plan I, III and IV: [Time frame: 0.25 - 168 hrs post drug administration]
- Plan II: [Time frame:Day 1: 0.25 - 12 hours, Day 2-6: 0, 2, 4 Hours, Day: 0.25-168 hours post drug administration]
Effects of food on the pharmacokinetics will be assessed in healthy subjects.
Measured: 7 Days
Pharmacodynamics
Plasma glucose, serum insulin, C-peptide and glucagoan estimate -
- Plane I and Plan III [Time frame: Day 0 and Day 1: upto 4 hours post oral glucose 75 grams]
- Plan II [Time frame: Day 0, Day 1 and Day 7: upto 4 hours post oral glucose 75 grams]
- Plan IV: [Time frame: Period 2: Day 0 and Day 1: upto 4 hours post meal]
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012
Why it stopped: Not achieved the objective till 4 mg single dose
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zydus Lifesciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajendrakumar H Jani, PhD(Medical), Study director, Clinical R&D, Zydus Research Center, Cadila Healthcare Limited, Moraiya, Ahmedabad-382213, Gujarat, IndiaKevinkumar Kansagra, MD, Principal investigator, Clinical R&D, Zydus Research Center, Cadila Healthcare Limited, Moraiya, Ahmedabad-382213, Gujarat, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472809
- Sponsor's protocol ID
- ZYGK1/1001
- Other IDs
- CTRI/2011/12/002249
- Status last verified
- Nov 2015
- First submitted
- 9 Nov 2011
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Placebo Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZYGK1, a Novel Glucokinase Activator, Following Oral Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01472809
- Acronym / sponsor ID
- ZYGK1/1001
- Conditions
- Diabetes
- Keywords
- ZYGK1, Cadila, Zydus, ZRC, Zydus Research Center, Phase 1, Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Not achieved the objective till 4 mg single dose
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Zydus Lifesciences LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- First posted
- 17 Nov 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.
The purpose of this study is to determine (1) whether ZYGK1 is safe and well tolerated, (2) the pharmacokinetics (what body does to ZYGK1) and (3) pharmacodynamics (what drugs does to the body) in the healthy and diabetic subject.
Detailed description
This study will be a randomized, double blind, placebo controlled study and is divided into four plans:
- Plan I: Single Ascending Dose (SAD) Study
- Plan II: Multiple Ascending Dose (MAD)Study
- Plan III: Gender Effect study
- Plan IV: Food Effect study
First Plan I, Plan III and Plan IV will be conducted in healthy volunteers. After reviewing the results, decision shall be taken whether the multiple ascending doses shall be studied in healthy human volunteers or in subjects with type 2 diabetes.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets |
| ZYGK1 | Experimental | Drug: ZYGK1ZYGK1 tablets; 0.125, 0.25, 0.5, 1, 2, ... mg. Dose escalation will continue till single AE occurs in any block of 3 volunteers on ZYGK1 or pharmacokinetic (dose linearity) saturation is reached or desired PK/PD effect is achieved |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 18-45 years
- Mentally, physically, and legally eligible to give informed consent
- Male and female volunteers weighing between 50-75 kg and 45-75 kg (4) respectively.
- Ability to communicate effectively with the study personnel
- Willingness to adhere to the protocol requirements
Key exclusion criteria (18 listed)
- Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYGK1 formulation
- Presence or history of pancreatitis at any time (Serum Amylase/Serum Lipase more than upper normal limit (UNL))
- Presence or history of severe gastrointestinal disease in the last 6 months
- Presence or history of renal insufficiency at any time (serum creatinine >UNL)
- Active liver disease and/or liver transaminases greater than 1.5 X UNL
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 |
|---|---|---|
| ZYGK1ZYGK1 Tablets: 0.125, 0.25, 0.5, 1, 2, .... mg. Dose escalation will continue till single AE occurs in any block of 3 volunteers on ZYGK1 or pharmacokinetic (dose linearity) saturation is reached or desired PK/PD effect is achieved | Drug | ZYGK1 |
| PlaceboPlacebo Tablets: 0.125, 0.25, 0.5, 1, 2, ... mg | Drug | Placebo |
Primary outcome
Safety and tolerability
Time frame: Upto 14 Days
Safety and tolerability for- * Plan I, Plan III and Plan IV [Time frame: up to Day 8] * Plan II [Time frame: upto Day 14] Frequency of adverse events will be assessed at each dose level.
2 secondary outcomes
Pharmacokinetics
Time frame: 7 Days
Pharmacodynamics
Time frame: 7 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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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.
Rajendrakumar H Jani, PhD(Medical) study director
Clinical R&D, Zydus Research Center, Cadila Healthcare Limited, Moraiya, Ahmedabad-382213, Gujarat, India
Kevinkumar Kansagra, MD principal investigator
Clinical R&D, Zydus Research Center, Cadila Healthcare Limited, Moraiya, Ahmedabad-382213, Gujarat, India
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 ZYGK1 in people with Diabetes, run by Zydus Lifesciences Limited at 1 site in India.
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 7 inclusion and 18 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: paused, as of the sponsor's last update on 24 Nov 2015. 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 India. 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?
Results are not available in the source record.
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?
Safety and tolerability (time frame: Upto 14 Days). 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 24 Nov 2015.