A PHASE I STUDY OF HRF-4467, A NEW ANTI-HIV DRUG, TO EVALUATE THE SAFETY AND DRUG LEVELS IN BLOOD (PK), WHILE FASTING AND FED CONDITIONS, IN HEALTHY MALE VOLUNTEERS

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2019/02/017597
• Date of registration: 12-02-2019
• Prospective Registration: Yes
• Primary sponsor: Hetero Labs Limited
• Public title: A PHASE I STUDY OF HRF-4467, A NEW ANTI-HIV DRUG, TO EVALUATE THE SAFETY AND DRUG LEVELS IN BLOOD (PK), WHILE FASTING AND FED CONDITIONS, IN HEALTHY MALE VOLUNTEERS
• Scientific title: A RANDOMIZED, PHASE-I, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-ESCALATION (SINGLE ASCENDING DOSE) STUDY TO EVALUATE SAFETY, TOLERABILITY & PHARMACOKINETICS OF HRF-4467 SOLUTION OF HETERO LABS LIMITED, INDIA IN NORMAL, HEALTHY, ADULT, HUMAN MALE SUBJECTS UNDER FASTING CONDITION AND EVALUATION OF FOOD EFFECT WITH ANY ONE COHORT OF SINGLE ASCENDING DOSE
• Date of first enrolment: 18-02-2019
• Target sample size: 48
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=31267
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 1

Countries of recruitment

India

Contacts

• Name: Dr Kiran Marthak
• Affiliation: Lambda Therapeutic Research Ltd

• Name: Dr Shubhadeep Sinha
• Affiliation: Lambda Therapeutic Research Ltd

Key inclusion & exclusion criteria

Inclusion criteria: a) Non-smoking, normal, healthy adult male human volunteers between 18 to 45 years of age (both inclusive) living in and around

Ahmedabad city or western part of India.

b) Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg per height in meter square.

c) Volunteer should be literate

d) Not having any significant disease in medical history or clinically significant abnormal findings during screening, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest (P/A view) recordings.

e) Able to understand and comply with the study procedures, in the opinion of the principal/Coinvestigator.

f) Able to give voluntary written informed consent for participation in the trial.
Exclusion criteria: a) Known hypersensitivity or idiosyncratic reaction to normally used medicines such as antihistamines, NSAIDs or any of the excipients

or related drug.

b) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.

c) Ingestion of a medicine (CYP inducers or inhibitors including herbal medicines) at any time within 14 days before dosing. In any

such case subject selection will be at the discretion of the Principal Investigator.

d) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.

e) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.

f) A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week (A

standard drink is defined as 360 ml of beer or 150 mL of wine or 45 mL of 40 percentage distilled spirits, such as rum, whisky, brandy

etc) or consumption of alcohol or alcoholic products within 48 hours prior to dosing.

g) Smokers, or who have smoked within last six months prior to start of the study.

h) The presence of clinically significant abnormal laboratory values during screening.

i) History or presence of seizure or psychiatric disorders.

j) A history of difficulty in donating blood.

k) Difficulty in swallowing tablet/capsule.

l) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.

m) Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication

n) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.

o) A positive test result for HIV (I & II) antibody.

p) Consumption of Grapefruits or its products within 72 hours prior to dosing.

q) An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine. In any such case subject selection will be at the discretion of the Principal Investigator.

Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: HRF-4467 Solution 20 mg/mL of
Hetero Labs Limited, India.: Dose: 20 mg/mL; Frequency:
single ascending dose; Mode of Administration: Oral; Duration of treatment: single ascending dose
Control Intervention1: NA: NA

Primary Outcome(s)

Assessment of safety, tolerability & pharmacokinetics of HRF-4467 in Healthy Adult Male Human subjects & evaluation of food effect with one cohort in Single Ascending Dose and

the safety of the subjects.Timepoint: pre dose (0.000) and at 0.250, 0.500, 1.000, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 14.000, 16.000, 20.000, 24.000, 36.000, 48.000, 72.000 and 96.000 hours post dose

Secondary Outcome(s)

NATimepoint: NA

Secondary ID(s)

0375-18 , Version no 1.0, Date: 14 August 2018

Source(s) of Monetary Support

Hetero Labs Limited, 7-2-A2, Hetero Corporate, Industrial Estates, Sanathnagar, Hyderabad-500018, Telangana, India. Tel. No. 04023704923, Fax No. 04023704926

Ethics review

Status: Approved
Approval date: 21/09/2018
Contact:

Riddhi Medical Nursing Home Institutional Ethics Committee, Dr. Kiran Marthak