Pharmacokinetic Interactions Between HRF-10071, Darunavir and Ritonavir
- Registration Number
- CTRI/2022/10/046158
- 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
1. Healthy adult human participants of either sex aged between 18 and 45 years (including both).
2. Subjects weight within clinically acceptable normal range according to normal values for Body Mass Index (18.50 to 30.00 kg per m2) (both inclusive) with minimum of 55 kg weight.
3. Subject with Hemoglobin level greater or equal to 12.0 gm% at the time of screening.
4. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
5. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
6. Subjects having clinically acceptable chest X-Ray (PA view) at screening, if taken.
7. Subjects having Creatinine clearance more than 90 ml per min at screening as per CKD-EPI Equation.
8. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
9. Subjects having negative Urine Alcohol test.
10. Subjects should be Non-smokers.
11. Subjects willing to adhere to the protocol requirements and to provide written informed consent.
12. For Men:
Subjects willing to follow approved birth control methods (a double barrier method) 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. Subjects should also not donate sperm during this time.
13. Subjects having negative Urine Pregnancy test at screening and Serum Beta-hCG (pregnancy test) at admission of Period 01 (only for women).
14. For Women:
Women of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), non-hormonal intrauterine device (IUD), abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam, or
Postmenopausal for at least 01 year, if less than 1 year, then following acceptable contraceptive measures as mentioned above or
Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
1. Hypersensitivity to Darunavir, Ritonavir and HRF-10071 or related class of drugs or any of its excipients or heparin.
2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, urogenital, dermatological, neurological or psychiatric disease or disorder.
3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 01 month prior to Period 01 first dosing.
4. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
5. 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 percent distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within
48 hours prior to first dosing) or drug abuse.
6. History or presence of asthma, urticaria or other significant allergic reactions.
7. History or presence of significant gastric and or duodenal ulceration.
8. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
9. History or presence of cancer or basal or squamous cell carcinoma.
10. Difficulty with donating blood.
11. Difficulty in swallowing solids like tablets or capsules.
12. Use of any prescribed medications or OTC medications, herbal products including traditional herbal remedies (e.g., Ayurveda, Unani, Traditional Chinese medicines St. Johnââ?¬•s wort etc.), homeopathic products and vaccines
during last 30 days prior to first dosing in Period 01.
13. Alanine aminotransferase (ALT) greater and equal to 1.5 times upper limit of normal (ULN); Aspartate aminotransferase (AST) greater and equal to 1.5 times ULN; Alkaline phosphatase greater and equal to 1.5 times ULN; Bilirubin greater than 1.5 Ã?â?? ULN (isolated bilirubin greater and equal to 1.5 Ã?â?? ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).
14. Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
15. Any Grade 2 to 4 laboratory abnormality 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 laboratory abnormality is allowed within a single screening period to determine eligibility.
16. Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction, sinoatrial pauses, bundle branch block, or conduction abnormality) which, in the opinion of the investigator will interfere with the safety for the individual participant.
17. Major illness during past 03 months.
18. History or presence of seizure or psychiatric disorders.
19. Volunteer who has donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.
20. Consumption of grapefruit or grapefruit juice products within 72.00 hours prior t
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC(0-t)ss, Cmax.ss, and Ct.ss for Darunavir and Ritonavir <br/ ><br>AUC(0-t)ss, Cmax.ss, and Ct.ss for HRF-10071 <br/ ><br>Timepoint: Period 01: PK Samples for Darunavir and Ritonavir <br/ ><br>A total of 35 blood samples each 4.0 ml will be collected. <br/ ><br> <br/ ><br>Period 02: PK Samples for HRF-10071 <br/ ><br>A total of 28 blood samples each 3.0 ml will be collected. <br/ ><br> <br/ ><br>Period 03: PK Samples for Darunavir, Ritonavir and HRF-10071 <br/ ><br>A total of 37 blood samples will be collected. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Safety and tolerability parameters for AEs/SAEs, observed and change from baseline clinical laboratory assessments, ECGs, and vital sign measurements <br/ ><br>Tmax.ss and t1/2 for HRF-10071 <br/ ><br>Tmax.ss and t1/2 for Darunavir and RitonavirTimepoint: Period 01: PK Samples for Darunavir and Ritonavir <br/ ><br>A total of 35 blood samples each 4.0 ml will be collected. <br/ ><br> <br/ ><br>Period 02: PK Samples for HRF-10071 <br/ ><br>A total of 28 blood samples each 3.0 ml will be collected. <br/ ><br> <br/ ><br>Period 03: PK Samples for Darunavir, Ritonavir and HRF-10071 <br/ ><br>A total of 37 blood samples will be collected.