Healthy, Overweight and/or Obese SubjectsPhase 1NCT01764425
Clinical Trial to Study the Safety Tolerability, Pharmacokinetics, Food Effect & Pharmacodynamics of a New Compound P7435 in Healthy, Overweight and/or Obese Subjects
A Phase 1 study testing P7435 in people with Healthy, Overweight and/or Obese Subjects, run by Piramal Enterprises Limited at 2 sites in India.
Trial summary
Clinical trial to study the safety tolerability, pharmacokinetics, food effect and pharmacodynamics of a new compound P7435 in in healthy, overweight and/or obese subjects Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight and/or Obese Subjects
- What is being tested?
- P7435
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesIndia
- Study dates
- May 2012to Feb 2013
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willingness and are able to provide a written informed consent to participate in the study.
- Healthy adult male subjects aged between 18 and 45 (both inclusive) years old
- BMI between 19 and 23 kg/m2. Overweight (BMI between 23 and 25kg/m2) and/or obese (BMI between 25 and 35 kg/m2) but otherwise healthy subjects in PartB .
- Healthy as determined by the investigator
- Smoking less than 10 cigarettes per day and able to refrain from smoking during confinement.
- Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, coke, chocolate, "power drinks") and grapefruit juice to admission.
Who cannot join
- Employees of the sponsor or clinical sites.
- Female subjects.
- No past or current serious diseases of any organ will be allowed. Exceptions may be non-malignant skin diseases, childhood asthma and other conditions as per the Investigator's discretion and discussed with the Sponsor a priori. History of significant gastrointestinal disease or other significant diseases including cardiac, renal or liver impairment.
- History of sleep apnea, irregular sleep/wake cycle or working in night shifts.
- Acute disease state
- History of hypo/hyperthyroidism or repeated abnormal TSH values at screening or obesity of endocrine origin.
Show all 12Show fewer
- History of alcoholism for more than 2 years
- Positive serology for human immunodeficiency virus (HIV-1/2) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- Positive findings in urine drug screen / alcohol breath test.
- Participation in another clinical trial within 90 days of the first drug administration.
- Intake of more than 8-10 cups of coffee and/or tea per day and consumption of methyl xanthine-containing beverages (tea, coffee, cola drinks, chocolate) within 48 hours prior to study.
- Donation of blood (i.e. 350 ml) within 90 days before Day -1 of the first treatment period.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Veeda Clinical Research
Ahmedabad, Gujarat, 380015
Piramal Clinical Research
Hyderabad, Andhra Pradesh, 500013
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and Pharmacodynamics of Single and Multiple Ascending Doses of P7435 in Healthy, Overweight and/or Obese Subjects
Clinical trial to study the safety tolerability, pharmacokinetics, food effect and pharmacodynamics of a new compound P7435 in in healthy, overweight and/or obese subjects
Read the detailed description
- A phase I, randomized, double-blind, placebo-controlled, dose escalating study of P7435 to determine the safety, tolerability, pharmacokinetics, food effect and pharmacodynamics of single and multiple ascending doses of P7435.
- Subjects participating will be either healthy subjects or healthy overweight and/or obese subjects. In this study, overweight/obese are defined as subjects having a BMI of 23 kg/m2 and above.
- The study will be conducted in 3 parts as follows: Part A will consist of the Single Ascending Dose (SAD) study, Part B will consist of the Multiple Ascending Dose (MAD) study and Part C will consist of the Food Effect study.
- Being tested
- P7435
- Keywords
- P7435, Healthy,overweight and or obese subjects, Single ascending dose, Multiple ascending dose, Pharmacokinetics
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P7435Drug
It is oral DGATI inhibitor with potential in dyslipidemia and T2DM
| Study group | Role | What they receive |
|---|---|---|
| P7435 | Active comparator | Tablets for once daily oral administration, For SAD part of the study dose would be 10 mg for Cohort 1; Cohorts 2, 3, 4 and 5 will be dosed subsequently at 30 mg, 100 mg, 300 mg, 1000 mg respectively Dose for MAD and food effects part of the study would be based on SAD study results Receives: Drug: P7435 |
| Placebo | Placebo comparator | Placebo tablets for oral administration Receives: Drug: P7435 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
- Number of participants with adverse events in the single and multiple ascending dose studies.
Measured: Up to Day 5
Effect of food on drug concentrations
Measured: Day 1
Secondary outcomes (1)
Pharmacokinetics profile (Cmax, Tmax, and AUC)
- The PK profile will be derived from the P7435 plasma concentration data.
- A non compartmental model will be used to analyze the plasma levels of P7435
Measured: Day 1 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startMay 2012
- Primary completionSep 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, Overweight and/or Obese SubjectsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piramal Enterprises Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Madhavi Latha Kodru, Principal investigatorDr Dharmesh Domadia, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764425
- Sponsor's protocol ID
- P7435/66/11
- Status last verified
- Jul 2013
- First submitted
- 20 Dec 2012
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and Pharmacodynamics of Single and Multiple Ascending Doses of P7435 in Healthy, Overweight and/or Obese Subjects
- ClinicalTrials.gov ID
- NCT01764425
- Acronym / sponsor ID
- P7435/66/11
- Keywords
- P7435, Healthy,overweight and or obese subjects, Single ascending dose, Multiple ascending dose, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Piramal Enterprises LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 Jan 2013 (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.
Clinical trial to study the safety tolerability, pharmacokinetics, food effect and pharmacodynamics of a new compound P7435 in in healthy, overweight and/or obese subjects
Detailed description
- A phase I, randomized, double-blind, placebo-controlled, dose escalating study of P7435 to determine the safety, tolerability, pharmacokinetics, food effect and pharmacodynamics of single and multiple ascending doses of P7435.
- Subjects participating will be either healthy subjects or healthy overweight and/or obese subjects. In this study, overweight/obese are defined as subjects having a BMI of 23 kg/m2 and above.
- The study will be conducted in 3 parts as follows: Part A will consist of the Single Ascending Dose (SAD) study, Part B will consist of the Multiple Ascending Dose (MAD) study and Part C will consist of the Food Effect study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P7435 | Active comparator | Drug: P7435Tablets for once daily oral administration, For SAD part of the study dose would be 10 mg for Cohort 1; Cohorts 2, 3, 4 and 5 will be dosed subsequently at 30 mg, 100 mg, 300 mg, 1000 mg respectively Dose for MAD and food effects part of the study would be based on SAD study results |
| Placebo | Placebo comparator | Drug: P7435Placebo tablets for oral administration |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Willingness and are able to provide a written informed consent to participate in the study.
- Healthy adult male subjects aged between 18 and 45 (both inclusive) years old
- BMI between 19 and 23 kg/m2. Overweight (BMI between 23 and 25kg/m2) and/or obese (BMI between 25 and 35 kg/m2) but otherwise healthy subjects in PartB .
- Healthy as determined by the investigator
- Smoking less than 10 cigarettes per day and able to refrain from smoking during confinement.
Key exclusion criteria (12 listed)
- Employees of the sponsor or clinical sites.
- Female subjects.
- No past or current serious diseases of any organ will be allowed. Exceptions may be non-malignant skin diseases, childhood asthma and other conditions as per the Investigator's discretion and discussed with the Sponsor a priori. History of significant gastrointestinal disease or other significant diseases including cardiac, renal or liver impairment.
- History of sleep apnea, irregular sleep/wake cycle or working in night shifts.
- Acute disease state
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 |
|---|---|---|
| P7435It is oral DGATI inhibitor with potential in dyslipidemia and T2DM | Drug | P7435, Placebo |
Primary outcome
Number of participants with adverse events
Time frame: Up to Day 5
- Number of participants with adverse events in the single and multiple ascending dose studies.
Effect of food on drug concentrations
Time frame: Day 1
1 secondary outcome
Pharmacokinetics profile (Cmax, Tmax, and AUC)
Time frame: Day 1 and Day 14
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
Related trials for Healthy, Overweight and/or Obese Subjects
RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweight/Obese Subjects
Healthy Subjects
RecruitingPhase 1
A Phase 1 Study of GZC8072 Tablets Following a Single Dose in Healthy Study Participants and Multiple Doses in Obese/Overweight Study Participants
Healthy Subjects;Overweight or Obesity
Not yet recruitingPhase 1
A Clinical Trial of TQF6422 Injection in Overweight or Obese Healthy Subjects.
Obesity / Overweight
Active, not recruitingPhase 1
Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes
Healthy Subjects, Obesity
Active, not recruitingPhase 1
A Study to Assess Adverse Events, Tolerability, and Pharmacokinetics of Subcutaneous Injections of ABBV-295 in Healthy Adult Japanese Participants With Overweight or Obesity.
Healthy Volunteer
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.
Dr Madhavi Latha Kodru principal investigator
Dr Dharmesh Domadia principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing P7435 in people with Healthy, Overweight and/or Obese Subjects, run by Piramal Enterprises Limited at 2 sites 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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early. 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?
Number of participants with adverse events (time frame: Up to Day 5). The study lists 2 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 9 Jul 2013.