NCT01801293已完成1 期
A Phase 1 Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of GS-5806
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Urine and fecal recovery of total [14C]-radioactivity
研究概览
简要总结
This is a single center, open-label, Phase 1 study to determine the mass balance of of GS-5806 following administration of a single, oral dose of radiolabeled [14C]-GS-5806 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Have a calculated body mass index (BMI) from 19 to 30 kg/m2 at study screening.
- •In the opinion of the Investigator, subjects must be in good health based upon medical history, physical examination (including vital signs), and screening and baseline laboratory evaluations (hematology, chemistry, and urinalysis must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance).
- •Agree to utilize a highly effective method of contraception during heterosexual intercourse from baseline throughout the study period and for 90 days following discontinuation of study drug.
- •Refrain from sperm donation from Day -1 through completion of the study and continuing for at least 90 days from the date of last dose of study drug.
- •Have a creatinine clearance (CLcr) > 80 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation.
- •Anticipated, regular, average bowel movement of 1-2 per day.
排除标准
- •Smokers, use of nicotine or nicotine-containing products within 90 days prior to the first dose of study drug. Smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine ≥200 ng/mL at screening.
- •A positive HIV-1 antibody, Hepatitis B surface antigen (HBsAg), or Hepatitis C antibody test result.
- •Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
- •Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to study dosing.
- •Have participated in studies using radiomaterials or ionizing radiations or have been otherwise exposed to significant diagnostic (excluding dental X-rays), therapeutic, or occupational radiation.
- •Current alcohol or substance abuse as judged by the Investigator or as determined by a positive alcohol or drug test at screening or baseline visit.
- •Have poor venous access and are unable to donate blood.
- •Have donated blood within 56 days of study dosing or plasma within 7 days of study dosing.
- •Have been vaccinated within 90 days of study dosing or, for the influenza vaccine, within 14 days prior to study dosing.
- •Have taken any prescription medications or over-the-counter medications, including herbal products, or medications that affect gastric pH (ie, antacids, H2RAs, and/or proton pump inhibitors) within 28 days of commencing study drug dosing with the exception of vitamins, acetaminophen, and ibuprofen.
- •Have taken any systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies).
- •Evidence of any of the following:
- •Clinically significant ECG abnormalities.
- •Syncope, palpitations, or unexplained dizziness.
- •Liver disease (including known Gilbert's Disease) or clinical evidence of liver injury or hepatic synthetic dysfunction.
- •Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions requiring prolonged (>6 months) medical treatment.
- •History of medical or surgical treatment that permanently alters the gastric conditions (eg, gastrectomy).
- •Significant drug sensitivity or drug allergy.
- •Known hypersensitivity to sulfa drugs.
- •Known hypersensitivity to the study drug, metabolites or formulation excipients.
研究组 & 干预措施
Intervention Arm
Experimental
One-time single dose of 50 mg radiolabeled GS-5806 administered orally in 3 capsules in the morning.
干预措施: GS-5806 (Drug)
结局指标
主要结局
Urine and fecal recovery of total [14C]-radioactivity
时间窗: 22 days
The primary outcome measure of this study is the urine and fecal recovery of total \[14C\]-radioactivity.
次要结局
- Recovery of [14C]-GS-5806(22 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Mass Balance Study of [14C] TAS-205 in Healthy VolunteersHealthy Male SubjectsNCT04825431Taiho Pharmaceutical Co., Ltd.6
撤回
1 期
A Study to Assess Mass Balance, Pharmacokinetics (PK), and Metabolism of Orally Administered [14 C]-TAK-659 in Participants With Advanced Solid Tumor and/or Lymphoma MalignanciesAdvanced Solid NeoplasmsLymphoma NeoplasmsNCT03338881Calithera Biosciences, Inc
撤回
1 期
A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK2248761 Administered as an Oral Suspension to Healthy Adult SubjectsInfection, Human Immunodeficiency VirusNCT01273103ViiV Healthcare
撤回
1 期
Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]PF-07321332 in Healthy Male Participants.Healthy ParticipantsNCT05178654Pfizer
已完成
1 期
Oral Bioavailability and Mass Balance Trial With PimasertibLocally Advanced or Metastatic Solid TumorsNCT01713036Merck KGaA, Darmstadt, Germany6