A Study to Determine the Safety, Tolerability and Pharmacokinetics of PMZ-2010 (Centhaquin) in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 4 May 2015
• Main ID: NCT02408731
• Date of registration: 20/03/2015
• Prospective Registration: No
• Primary sponsor: Pharmazz, Inc.
• Public title: A Study to Determine the Safety, Tolerability and Pharmacokinetics of PMZ-2010 (Centhaquin) in Healthy Volunteers
• Scientific title: A Randomized, Double-blind, Placebo-controlled Phase I Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of PMZ-2010 (Centhaquin) in Healthy Male Volunteers
• Date of first enrolment: October 2014
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02408731
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

India

Contacts

• Name: Ashish O Goyal, MD
• Affiliation: Jehangir Clinical Development Centre Pvt. Ltd.

Key inclusion & exclusion criteria

Inclusion Criteria: Subjects to be enrolled in this trial must fulfill all of these
criteria:

- Sex: male

- Age: 18-60 yr old, both inclusive

- Having a Body Mass Index (BMI) between 18.5-28 kg / m2 (both inclusive) and body
weight not less than 45 kg

- Full comprehension: ability to comprehend the full nature and purpose of the study,
including possible risks and side effects; and to comply with the requirements of the
entire study

- Voluntarily given written informed consent to participate in this study

- Be of normal health as determined by the principal investigator from medical history,
physical examination and laboratory investigations, 12-lead ECG and X-ray chest of
the subjects performed within 10 days prior to the admission of the study

- Ability and willingness to abstain from alcohol, methylxanthine-containing beverages
or food (coffee, tea, coke, chocolate, "power drinks") and grapefruit (juice) from 48
h prior to each admission until study completion

Exclusion Criteria: Subjects meeting any of these criteria will not be enrolled in the
study:

- Employees of JCDC or Pharmazz India Private Limited

- Not willing to use contraceptives (preferably condoms) during sexual activity for the
period of 3 months from the date of check-in

- History of hypersensitivity and / or intolerance to Centhaquin or any other related
compounds.

- History of anaphylaxis to drugs or allergic reactions in general, which the
Investigator considers may affect the outcome of the study.

- Clinically abnormal ECG and Chest X-ray.

- Physical findings: clinically relevant abnormal physical findings (including body
temperature) suggesting underlying pathologies or those which could interfere with
the objectives of the study.

- Subjects with impaired renal function as measured by glomerular filtration rate <90
mL/min/1.73m2 estimated using the modification of diet in renal disease (MDRD)
formula [GFR for Male =186 × (Serum Creatinine)-1.154 × Age-0.203 ]12

- Laboratory values that are significantly different than the normal reference range
and/or are deemed to be of clinical significance by the investigator

- Presence of reactive disease markers of HIV 1 and II, HBsAg, HCV or VDRL.

- Positive for alcohol breath test and/or urine drug screen (barbiturates,
benzodiazepines, amphetamine, cocaine, opiates, tetra-hydro cannabinol).

- Any evidence of organ dysfunction or any clinically significant deviation from the
normal, in physical or clinical determinations.

- Diseases: relevant history of renal, hepatic, cardiovascular, respiratory, skin,
haematological, endocrine, neurological or gastrointestinal diseases. History of
depression, psychosis, schizophrenia or any other severe psychiatric diseases, or
epilepsy, or any other illness that may interfere with the aim of the study. History
of any significant illness in the 4 weeks preceding the screening

- Medications: history of intake of any medications including over the counter
medications (OTC) and any herbal agents at least 4 weeks period prior to study drug
administration.

- Investigational drug trials: participation in the evaluation of any drug in the 3
months prior to the start of the study (dosing with IMP).

- Blood donation: Subjects who, through completion of this study, would have donated
and/or lost more than 300 mL of blood in the past 12 weeks Note: In case the blood
loss is = 200 mL; subject may be dosed 60 days after blood donation or last sample of
the previous study

- Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining
from smoking for the duration of each study period.

- History of drug dependence or alcoholics



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: PMZ-2010 (Centhaquin)

Primary Outcome(s)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: 7 days]

Secondary Outcome(s)

Phamacodynamics profile of PMZ-2010 [Time Frame: 7 days]

Composite of pharmacokinetics of PMZ-2010 in plasma [Time Frame: 24 hours]

Secondary ID(s)

CT-430-CENT-2012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors