None listed
Conditions
Interventions
Intervention1: HRF-10071 Tablet: Manufactured by: Hetero Labs Limited, India.
Strength: 10 mg, 20 mg, 40 mg and 100 mg
Control Intervention1: Placebo-
Identical formulation without active ingredient:
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: a)Non-smoking, normal, healthy adult male human volunteers between 18 to 45 years of age (both inclusive). b)Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg / height in meter2. 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 investigator. f)Able to give voluntary written informed consent for participation in the trial.
Exclusion criteria
Exclusion criteria: a)Known hypersensitivity or idiosyncratic reaction to normally used medicines such as anti-histamines, 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 prior to dosing of part 1/first IMP administration of part 2. 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 of part 1/first IMP administration of part 2. 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 If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received. n)A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies. o)A positive test result for HIV (1 and/or 2) antibody. p)Consumption of Grapefruits or its products within 72 hours prior to dosing of part 1/first IMP administration of part 2. q)An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to dosing of part 1/first IMP administration of part 2. In any such case subject selection will be at the discretion of the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess safety, tolerability & pharmacokinetics of single ascending dose and multiple ascending dose of HRF-10071, a HIV maturation inhibitor, in Tablet formulation for Hetero Labs Limited, India in Healthy Adult Male Human subjects under Fasting/Fed Condition & evaluation of food effect with one cohort in Single Ascending Dose (SAD). And To monitor the safety of the subjectsTimepoint: Time Points: Part I- pre dose and at 0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 14.0, 16.0, 20.0, 24.0, 36.0, 48.0, 72.0, 96.0, 120.0 and 144.0 hrs Post Part II Pre-dose: On day 01, Day 07, Day 12 and Day 14 prior to dosing. Post-dose Day-0 at 0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 14.0, 16.0, 20.0 and 24.0 hrs Day- 14 at 0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 14.0, 16.0, 20.0, 24.0, 48.0, 72.0 and 96.0 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha
Lambda Therapeutic Research Ltd
Outcome results
None listed