- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04011124
A Drug-drug Interaction Trial of Rifampicin Pharmacokinetics Effect on Fluzoparib
25 februari 2020 uppdaterad av: Jiangsu HengRui Medicine Co., Ltd.
A Single Center, Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Rifampicin on Fluzoparib in Healthy Male Subjects
The primary objective of the study was to assess the effect of repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Fluzoparib.
The secondary objective of the study was to assess the safety of Fluzoparib given alone versus Fluzoparib coadministered with Rifampicin.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
16
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310003
- First Affiliated Hospital of Zhejiang University School of Medicine
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 50 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
- Sign the informed consent form before the trial and fully understand the trial content, process and possible adverse reactions;
- Ability to complete the study as required by the protocol;
- Age on the date of signing the informed consent form is 18 to 50 years old (including both ends) and is limited to male subjects only;
- Male subjects are willing to have no birth plans in the next 6 months and voluntarily take effective contraception;
- The fasting weight is not less than 50kg, and the body mass index (BMI) is in the range of 18 kg/m2 to 28 kg/m2 (including both ends);
- Health status: no medical history of heart, liver, kidney, digestive tract, nervous system, mental abnormalities and metabolic abnormalities;
- Accepted physical examination results (vital signs, physical examination) and routine laboratory examination (blood routine, blood biochemistry, urine routine, etc.), 12-lead ECG, X-chest, abdominal B-ultrasound, etc. or no clinical significance if abnormal.
- Creatinine clearance (CLCr) ≥ 80 mL/min, and creatinine is less than or equal to the upper limit of normal
Exclusion Criteria:
- Participate in blood donation within 3 months before screening and donate blood volume ≥400mL or blood loss ≥400mL, participate in blood donation within 1 month before screening and donate blood volume ≥200mL or blood loss ≥200mL, or receive blood transfusion;
- Allergic constitution, including a history of severe drug allergy or drug allergy; a history of allergies to fluzoparib capsule or its excipients;
- with drug and/or alcohol abuse history, or alcohol, nicotine and drug screening positives, or drug abuse in the past five years or used drugs 3 months before the trial; and could not prohibit smoking and alcohol during the trial period ;
- with medical history of cardiovascular disease such as myocarditis, coronary heart disease, pathological arrhythmia, and stroke;
- Pulmonary diseases, including invasive lung disease, pneumonia, dyspnea, etc.;
- Chronic kidney disease, renal insufficiency, history of renal anemia;
- have a history of dysphagia or any history of gastrointestinal disease that affects drug absorption;
- any uncontrolled peptic ulcer, colitis, pancreatitis, etc.;
- Anyone who has undergone any surgery within the first 6 months of screening; has undergone any surgery that affects gastrointestinal absorption (including gastrectomy, bowel resection, stomach reduction, etc.);
- with acute disease that has been clinically determined by the investigator occurred within 1 month before screening;
- Other important organ diseases such as the nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolic and musculoskeletal system with clear medical history (such as uncontrolled diabetes, high blood pressure, etc.), enabling investigators considered unsuitable for participation in the study;
- Those who have taken any clinical trial drugs within 3 months;
- Take any drug that affects liver metabolism within 28 days before taking the investigational drug;
- Take any prescription or over-the-counter medication within 14 days before taking the investigational drug;
- Take any vitamin products or herbs within 14 days before taking the investigational drug;
- Clinical laboratory tests are abnormal and clinically significant, or other clinical findings indicate the following diseases, including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular disease;
- combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection;
- The subject refused to discontinue any beverage containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate, etc.) or alcoholic beverages or any juice, 48 hours before the investigational drug was administered until the end of the study;
- Strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.;
- The investigator believes that the subjects are not eligible to participate in this trial.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Rifampicin + Fluzoparib
|
single dose on Day 1 and Day 12
QD on Day 5-14 for 10 days
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Peak Plasma Concentration (Cmax) of Fluzoparib
Tidsram: Day 1 to Day 15
|
Day 1 to Day 15
|
|
Area under the plasma concentration versus time curve (AUC) of Fluzoparib
Tidsram: Day 1 to Day 15
|
Day 1 to Day 15
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: Up to Day 22
|
Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination, vital signs, adverse events (NCI-CTC AE 5.0), etc.
|
Up to Day 22
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
24 juli 2019
Primärt slutförande (Faktisk)
16 september 2019
Avslutad studie (Faktisk)
16 september 2019
Studieregistreringsdatum
Först inskickad
3 juli 2019
Först inskickad som uppfyllde QC-kriterierna
3 juli 2019
Första postat (Faktisk)
8 juli 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 februari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 februari 2020
Senast verifierad
1 februari 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Nukleinsyrasynteshämmare
- Enzyminhibitorer
- Antibakteriella medel
- Leprostatiska medel
- Cytokrom P-450 enzyminducerare
- Cytokrom P-450 CYP3A-inducerare
- Antituberkulära medel
- Antibiotika, Antituberkulära
- Cytokrom P-450 CYP2B6-inducerare
- Cytokrom P-450 CYP2C8 inducerare
- Cytokrom P-450 CYP2C19 inducerare
- Cytokrom P-450 CYP2C9 inducerare
- Rifampin
Andra studie-ID-nummer
- FZPL-I-110
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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