A study to evaluate pharmacokinetics interactions between HRF-10071 and Rilpivirene in healthy adult human participants.
- Registration Number
- CTRI/2022/07/044067
- Lead Sponsor
- Hetero Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
a) Non-smoking, healthy adult human participants of either sex between 18 to 45 years of age (both
inclusive). b) Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg I height in meter2.c) Hemoglobin level more than or equal to 12.0 gm % (for men) & more than or equal to 11.5 gm% (for women) at the time of screening.d) Creatinine clearance more than 90 ml/min at screening as per Cockcroft-Gault Equation.e) 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.f) Able to understand and comply with the study procedures, in the opinion of the principal investigator.g) Literate and able to give voluntary written informed consent for participation in the trial.h)For men :Participants willing to follow approved birth control methods for the duration of the study as judged by the investigator(s), such as (a double barrier method) condom with spermicide, condom with diaphragm or abstinence. Participants agree not to donate sperm during the entire course of study.i) For women: � Surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the participant) at least 6 months prior to study participation Or If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method (abstinence or double barrier contraception, i.e., condom + diaphragm,condom+ spermicidal or foam) or intra uterine device during the study.and �Urine Pregnancy Test at screening and Serum Pregnancy test at screening and prior to check-in of Period-I must be negative
a) Known hypersensitivity or idiosyncratic reaction to Rilpivirine or 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 haemopoi etic, renal,
hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological,
gastrointestinal or any other body system.
c)Ingestion of a medicine (any prescribed medications or OTC medications, herbal products
including traditional herbal remedies (e.g., Ayurveda, Unani, Traditional Chinese medicines St.
John wort etc.), and homeopathic products, CYP inducers or inhibitors) at any time within 30
days prior to first IMP administration of Period I and any vaccine (including COVID-19 vaccine)
from 30 days prior to first dosing of period I. In any such case participant selection will be at the
discretion of the Principal Investigator.
d)Any history or presence of asthma (including aspirin induced asthma) or nasa l 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 for men and more than 07 standard drinks per week for women
(A standard drink is defined as 360 ml of beer or 150 mL of wine or 45 mL of 40% distilled
spirits, such as rum, whisky, brandy etc.) or consumption of alcohol or alcoholic products within 48 hours prior to first lMP administration.
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, paiiicipant 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) Alanine aminotransferase (ALT) less than or equal to 1.5 times upper limit of normal (ULN)Aspartate aminotransferase(AST) less than or equal to 1.5 times ULN Alkaline phosphatase more than or equal to l.5 times ULN Bilirubin less than 1.5 ULN (isolated bilirubin 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin more than 35%).q) Any Grade 2 to 4 laboratory abnormality as per CTCAE grading at Screening, with the exception of creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides) and ALT/AST (described above), will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A
single repeat of any labora
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -To assess the effect of HRF-10071 on the steady state pharmacokinetic of Rilpivirine in healthy, adult human participants under fasting condition. <br/ ><br>�To assess the effect of Rilpivirine on the steady state pharmacokinetic of HRF-10071 in healthy, adult human participants under fasting conditionTimepoint: Pre-dose On day 1, Day 12, 13 and 14,15 prior dosing 0.000 (Day-01), 0.000 (Oay-12), 0.000 (Day-13), 0.000 (Day-14), 0.250 (Day-14), 0.500 <br/ ><br>For HRF- (Day-14), 1.000 (Day-14), 2.000 (Oay-14),3.000 (Day-14), 4.000 (Day-14), 6.000 (Day- 03 mL- 0.5 the 14), 7.000 (Day-14), 8.000 (Day-14), 10.000 volume (Day-14), 12.000 (Day-14), 14.000 (Day-14), 16.000 (Day-15), 20.000 (Day-15), 24.000 <br/ ><br>(Day-15)
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of HRF-10071 and Rilpivirine administered <br/ ><br>alone and when given concurrently in healthy human participants. -To evaluate steady state pharmacokinetic of HRF-10071 alone and when <br/ ><br>administered in combination with Rilpivirine. -To evaluate steady state pharmacokinetic of Rilpivirine alone and when administered in combination with HRF-10071.Timepoint: Day 1 to Day 14