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HealthyPhase 1NCT01910571

Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and Pharmacodynamics of Single and Multiple Ascending Doses of P7435 in Healthy, Overweight or Obese Subjects

A Phase 1 study testing P7435 in people with Healthy, run by Piramal Enterprises Limited at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single centre, phase I, randomized, double-blind, placebo-controlled, crossover, dose escalating study of P7435 using single and multiple doses, to be conducted in healthy male and female (Non child bearing) subjects having BMI between 19 to 40 kg/m2. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
P7435
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited States
Study dates
Aug 2013to Nov 2014
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects who are willing and are able to provide a written informed consent to participate in the study
  • Adult male and female subjects aged between 18 and 60 (both inclusive) years old
  • Subjects with a BMI between 19 to 40 kg/m2
  • Subjects, who are healthy, as having no clinically significant abnormalities in medical history, physical examination, clinical laboratory test results (hematology, biochemistry and urinalysis), vital signs and 12-lead electrocardiogram (ECG). The clinical significance of any abnormal finding in these parameters is left to the judgment of the Investigator, in conjunction with the Sponsor's clinical leader prior to enrolment
  • Subjects who smoke less than 10 cigarettes per day and are able to refrain from smoking during confinement
  • Subjects with the ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, coke, chocolate, "power drinks") and grapefruit juice starting from 72 hrs prior to the first admission (confinement) and continuing throughout the study
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  • Subjects who have a high probability for compliance with the study procedures including ability and willingness to swallow capsules during the study and allow withdrawing blood samples
  • Male subjects who are agreeable to use methods of contraception as specified in the protocol during the study and up to 30 days after the administration of the last dose of the study drug
  • Female subjects who are of non-child bearing potential defined as females who are either post menopausal [i.e. 1 year of natural (spontaneous) amenorrhea or break-through bleeding together with follicle stimulating hormone (FSH) confirmation of post-menopausal state at screening)] or surgically sterilized [hysterectomy, tubal occlusion, bilateral oophorectomy or bilateral salpingectomy]. FSH is required to document post-menopausal status in women <55 years of age or in women >55 with < 2 years since last menstrual period. FSH is not required for women >55 with >2 years since last menstrual period.

Who cannot join

  • Employees of the Sponsor, Clinical Research Organization (CRO) or clinical sites
  • Subjects in an acute disease state within 7 days before Day -1 of the study
  • Subjects with past or current diseases of any organ or system (such as, but not limited to, gastrointestinal, cardiac, renal, hepatic that is considered to be clinically significant by the Investigator, in conjunction with the Sponsor's clinical leader or subjects suffering from any condition that can affect the absorption, distribution, metabolism and excretion of orally administered medicines. Subjects with conditions such as non malignant skin diseases and childhood asthma can be included based on the Investigator's discretion and discussed with the Sponsor a priori)
  • Subjects with known congenital QTc prolongation or having QTcF value of >450 msec
  • Subjects with a history of sleep apnea, irregular sleep/wake cycle or working in night shifts
  • Subjects with a history of hypo/hyperthyroidism, (except those with thyroxin replacement and on stable dose since last 2 months) or repeated abnormal TSH values at screening or obesity of endocrine origin
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  • Subjects with a history of anaphylaxis or angioedema, or other clinically important food or drug allergy
  • Subjects with known lactose intolerance and / or intolerance / allergy to any component of the diet, including milk, soy and the high fat breakfast proposed to be given during the study
  • Subjects with a history of mental handicap, psychiatric disorders including (but not limited to) eating disorders, seizures or significant head trauma
  • Subjects with a history of drug abuse, addiction or use of recreational drug
  • Subjects with a history of alcoholism for more than 2 years or consumption of more than 3 alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study (one drink is equal to one unit of alcohol - one glass wine, half pint beer, one measure or ounce of spirit)
  • Subjects with a history of fainting from blood collections or vasovagal syncope
  • Subjects with prior exposure to P7435 or participation in any of the previous cohorts
  • Subjects with a positive serology for human immunodeficiency virus (HIV-1/2) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies
  • Subjects with positive findings in urine drug screen
  • Subjects with a positive finding in urine alcohol screen
  • Subjects who have participated in another clinical trial within 30 days prior to the first drug administration
  • Subjects who are consuming any prescription drugs (including, but not limited to, sedatives and steroids); herbal supplements (including, but not limited to, St. John's Extract); or any other drugs likely to cause pharmacokinetic interaction within 30 days or 5 half lives, before first drug administration whichever is longer. Subjects using any other over-the-counter drugs (with the exception of paracetamol/NSAIDs and multivitamins that may be allowed up to 3 and 7 days before admission to the clinic, respectively) within 14 days or 5 half lives, prior to the first drug administration. Subjects who have undergone any weight loss surgery or are taking weight loss medications (including alternate medicine products) within 90 days prior to first drug administration
  • Subjects following an unusual diet e.g. low caloric, low sodium, within 30 days prior to first drug administration
  • Subjects who have donated blood (i.e. 350 mL) within 90 days prior to first drug administration.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Facility: Profil® Institute for Clinical Research, Inc.

    Chula Vista, California, 91911

Other trials in United States

About this study

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and Pharmacodynamics of Single and Multiple Ascending Doses of P7435 in Healthy, Overweight or Obese Subjects.

  • This is a single centre, phase I, randomized, double-blind, placebo-controlled, crossover, dose escalating study of P7435 using single and multiple doses, to be conducted in healthy male and female (Non child bearing) subjects having BMI between 19 to 40 kg/m2.
  • The study will be conducted in 2 parts as follows: Part A will consist of the Single Ascending Dose (SAD) study and Part B will consist of the Multiple Ascending Dose (MAD) study.
Conditions
Healthy
Being tested
P7435, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P7435Drug

  • PlaceboOther

Study groups in NCT01910571
Study groupRoleWhat they receive
P7435Experimental* In Part A, there will be up to 6 cohorts of 8 subjects each (for the 2 cohorts undergoing food effect study, there will be 12 subjects in each cohort). At each dose level, every subject will participate in two periods (one with active, P7435 and the second period with matching placebo or vice versa) separated by appropriate wash-out period between the two periods. The randomization scheme will ensure that no subject undergoes the placebo period twice. * In Part B, there will be up to 3 cohorts of 10 subjects each. Each of the 3 cohorts will participate in two study periods of 10 days of dosing in each (one period with active, P7435 and the other period with matching placebo or vice versa) separated by appropriate wash-out period.
Receives: Drug: P7435
PlaceboPlacebo comparator* In Part A, there will be up to 6 cohorts of 8 subjects each (for the 2 cohorts undergoing food effect study, there will be 12 subjects in each cohort). At each dose level, every subject will participate in two periods (one with active, P7435 and the second period with matching placebo or vice versa) separated by appropriate wash-out period between the two periods. The randomization scheme will ensure that no subject undergoes the placebo period twice. * In Part B, there will be up to 3 cohorts of 10 subjects each. Each of the 3 cohorts will participate in two study periods of 10 days of dosing in each (one period with active, P7435 and the other period with matching placebo or vice versa) separated by appropriate wash-out period.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (single and multiple dose studies)

    • To determine the safety and tolerability of single (Part A) and multiple (Part B) ascending doses of P7435 in healthy, overweight or obese subjects

    Measured: 12-14 Months

Secondary outcomes (9)

  1. Food Effect

    • To determine the effect of food on the pharmacokinetics (PK) of P7435 following single oral doses in these subjects (Part A)
    • The pharmacokinetic parameters (but not limited to) calculated in the double-blind active period (fed) versus the open-label active period (fasted) will be considered for the determination of the food effect.
    • The following parameters will be calculated: Cmax, tmax, tlag, AUC0-t, AUC0-inf, %AUC extrapolated, AUC0-24, kel, t½ for each of the periods i.e., fasted versus fed.

    Measured: 12-14 Months

  2. Area under the plasma concentration (AUC)

    Part A: The PK profile will be derived from the P7435 plasma concentration data on Day 1.

    Part B: The PK profile will be derived from the P7435 plasma concentration data on Days 1 and 10. Trough levels will be compared to assess steady state.

    Measured: 12- 14 Months

  3. Peak Plasma concentration (Cmax)

    Part A: The PK profile will be derived from the P7435 plasma concentration data on Day 1.

    Part B: The PK profile will be derived from the P7435 plasma concentration data on Days 1 and 10. Trough levels will be compared to assess steady state.

    Measured: 12- 14 Months

  4. Time to peak plasma concentration (t-max)

    Part A: The PK profile will be derived from the P7435 plasma concentration data on Day 1.

    Part B: The PK profile will be derived from the P7435 plasma concentration data on Days 1 and 10. Trough levels will be compared to assess steady state.

    Measured: 12- 14 Months

  5. Change in Fasting serum lipids

    • Fasting serum lipids [total cholesterol, triglycerides, low-density lipoproteins (LDL C), high-density lipoproteins (HDL-C), very-low-density lipoproteins (VLDL), free fatty acids and apolipoprotein-B (Apo-B)] (Part B only)

    Measured: 12- 14 Month

  6. Change in Fasting plasma glucose

    Part B only

    Measured: 12- 14 Months

  7. Fat tolerance test

    • Fat tolerance test variables including peak and post-prandial glucose, insulin, C peptide, lipids, GLP-1 and GIP and inflammatory biomarkers such as malondialdehyde and β-hydroxy butyrate (Part A and B)

    Measured: 12- 14 month

  8. Fasting serum insulin

    Part B only

    Measured: 12 - 14 months

  9. Fasting serum C-peptide

    Part B only

    Measured: 12-14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

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
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01910571
Sponsor's protocol ID
P7435/76/12
Status last verified
Nov 2014
First submitted
22 Jul 2013
Last updated
26 Nov 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing P7435 in people with Healthy, run by Piramal Enterprises Limited 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 9 inclusion and 20 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 26 Nov 2014. 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?

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?

Number of participants with adverse events (single and multiple dose studies) (time frame: 12-14 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01910571.

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 26 Nov 2014.

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