NL-OMON49480已完成不适用
A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06882961 - PF-06882961 ADME trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer, Inc.
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age and Sex:
- •1. Male participants must be 18 to 54 years of age, inclusive, at the time of
- •signing the
- •informed consent document (ICD).
- •Type of Participant and Disease Characteristics:
- •2. Male participants who are overtly healthy as determined by medical
- •evaluation including medical history, physical examination, laboratory tests,
- •3. Participants who are willing and are able to comply with all scheduled
- •visits, treatment plan, laboratory tests, lifestyle considerations, and other
- •study procedures.
- •4. Body mass index (BMI) of 17.5 to 30 kg/m2; and a total body weight >=50 kg
- •Informed Consent:
- •5. Capable of giving signed informed consent as described in the protocol,
- •which includes compliance with the requirements and restrictions listed in the
- •informed consent document (ICD) and in this protocol.
排除标准
- •Medical Conditions:
- •1. Evidence or history of clinically significant hematological, renal,
- •endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
- •neurological, or allergic disease (including drug allergies, but excluding
- •untreated, asymptomatic, seasonal allergies at the time of dosing).
- •2. Any condition possibly affecting drug absorption (eg, gastrectomy,
- •cholecystectomy).
- •3. History of irregular bowel movements (eg, irritable bowel syndrome or
- •frequent episodes of diarrhea or constipation) or lactose intolerance.
- •4. Other acute or chronic medical or psychiatric condition including recent
- •(within the past year) or active suicidal ideation or behavior or laboratory
- •abnormality that may increase the risk associated with study participation or
- •investigational product administration or may interfere with the interpretation
- •of study results and, in the judgment of the investigator, would make the
- •participant inappropriate for entry into
- •this study.
- •Prior/Concomitant Therapy:
- •5. Use of prescription or non-prescription drugs and dietary and herbal
- •supplements within 14 days prior to the first dose of investigational product.
- •(Refer to Section 6.5 for additional details). As an exception, ibuprofen or
- •acetaminophen may be used at doses of <=1 g/day. Limited use of non-prescription
- •medications that are not believed to affect participant safety or the overall
- •results of the study may be permitted on a case-by-case basis following
- •approval by the sponsor.
- •Prior/Concurrent Clinical Study Experience:
- •6. Previous administration with an investigational drug within 60 days (or as
- •determined by the local requirement) preceding the first dose of
- •investigational product used in this study.
- •7. Known prior participation in a trial involving PF-06882961 or known
- •intolerance to a GLP-1R agonist.
- •Further criteria apply
研究者
相似试验
已完成
不适用
A PHASE 1, OPEN-LABEL, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C]PF-07081532 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07081532 IN HEALTHY MALE PARTICIPANTS USING A [14C]-MICROTRACER APPROACHObesityNL-OMON51763Pfizer6
已完成
不适用
A phase 1, open-label, 2-period, fixed sequence, study to investigate the absorption, metabolism and excretion of 14C-PF-06650833 and to assess the absolute bioavailability and fraction absorbed of PF-06650833 in healthy male subjects using a 14C-microdose approach.Rheumatoid ArthritisNL-OMON44374Pfizer, inc.6
已完成
不适用
A phase 1, open label, 2-period, fixed sequence, study to assess the mass balance, absolute bioavailability of 14C-PF-06826647 in healthy male participantsPsoriasis and ulcerative colitis1001796910003816NL-OMON50100Pfizer Inc.6
进行中（未招募）
1 期
An open-label, two-part study to investigate the drug-drug interaction potential of INE963 and KAE609 administered together, and the effect of food on pharmacokinetics and safety of INE963 in healthy participants.Infections and InfestationsMalariaISRCTN17232240ovartis Pharmaceuticals UK Limited30
撤回
不适用
A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF 14C-PF-06835919 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06835919 IN HEALTHY MALE PARTICIPANTS USING A 14C-MICROTRACER APPROACH.NL-OMON49734Pfizer Inc.6