Overall Study Design and Plan Sample Clauses
The 'Overall Study Design and Plan' clause defines the framework and methodology for conducting a research study or clinical trial. It typically outlines the study's objectives, the types of participants involved, the procedures to be followed, and the timeline for key activities. For example, it may specify whether the study is randomized, double-blind, or observational, and detail the phases or milestones to be achieved. This clause ensures that all parties have a clear, shared understanding of how the study will be conducted, thereby promoting consistency, compliance, and effective coordination throughout the project.
Overall Study Design and Plan. This study is an open-label, nonrandomized, multi-center, single-dose, parallel-group study to determine the PK, safety, and tolerability of LOXO-305 administered orally at a dose of 200 mg to fasted adult males and females with mild, moderate, or severe impaired hepatic function and healthy subjects with normal hepatic function. Hepatic function will be classified based on the CP classification of hepatic impairment (Table 3).9,10 Subjects will be recruited in this study so that up to 24 subjects with hepatic impairment (up to 8 subjects with mild impairment, up to 8 subjects with moderate impairment, and up to 8 subjects with severe impairment, per CP classification – assessed at Screening and verified at Check-in [Day -1]) and 8 to 24 subjects with normal hepatic function are enrolled, with the goal of having at least 6 subjects from each hepatic impairment group per CP classification and at least 6 subjects with normal hepatic function complete the study. Hepatically impaired subjects will be assigned to groups according to CP scores at Check-in (Day -1) to ensure stability of hepatic impairment and subject safety, as determined by the Investigator [or designee]. Subjects will be enrolled within the following groups based on their CP score at Screening and Check-in (Day -1) as judged by the Investigator (or designee), Covance Medical Monitor, and Sponsor: • Group 1: Matched-control healthy subjects with normal hepatic function; • Group 2: Subjects with mild hepatic impairment (CP Class A, score of 5 or 6); • Group 3: Subjects with moderate hepatic impairment (CP Class B, score of 7 to 9); • Group 4: Subjects with severe hepatic impairment (CP Class C, score of 10 to 15). A parallel-design strategy will be adopted for the hepatic impairment groups, with interim reviews (as detailed in Section 8.2) of the safety data after the first 2 subjects from Group 2 (mild hepatic impairment subjects) and Group 3 (moderate hepatic impairment subjects) and matched-control healthy subjects are enrolled and have completed all study-related assessments including the follow-up phone call. Each matched-control healthy subject (Group 1) will be demographically matched (1:1) by age (± 10 years), BMI (± 20%), and sex to the completed hepatic impairment subject(s). Should another hepatic impairment subject be identified with whom an already enrolled healthy subject is demographically matched, the healthy subject may also be matched with that impaired subject as long as the i...
Overall Study Design and Plan. This is an open label, dose-escalating, sequential cohort study assessing the safety, tolerability, and biological activity of a single i.vt. injection of 0.2 mg, 1.0 mg and 2.0 mg RBM-007 administered in a total of approximately nine subjects with exudative AMD. Nine subjects in three dose cohorts (3 subjects each cohort) will receive a single i.vt. injection of RBM-007 in the study eye. Decisions regarding dose escalation will be based on the recommendations of the Safety Review Team consisting of external Retina Specialists and the Medical Monitor. Dose-Limiting Toxicity response observed in any cohort will result in termination of the dose escalation. The study is designed to include a primary endpoint at Day 28 following RBM-007 injection, and Day 56 follow-up for each subject.
Overall Study Design and Plan. This study is an open-label, nonrandomized, multi-center, single-dose, parallel-group study to determine the PK, safety, and tolerability of LOXO-305 administered orally at a dose of 200 mg to fasted adult males and females with impaired renal function and healthy subjects with normal renal function. Renal function will be classified based on the baseline eGFR calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) study equation.10 Baseline eGFR will be obtained for all subjects (ie, subjects with renal impairment and matched-control healthy subjects) by taking the mean of the eGFR obtained from Screening and from historical values obtained within a 3-month period from Screening. If no historical eGFR value is available, a second Screening eGFR sample will be taken during the Screening period (≥ 14 days apart) and the mean of the 2 values will be used as the baseline eGFR for group assignment. Individual eGFR values recorded for each measurement contributing to the subject mean baseline value must fall within the specified eGFR ranges for each group (ie, matched-control healthy subjects and subjects with severe renal impairment [and subjects with mild and/or moderate renal impairment, if they are enrolled]) to categorize subjects’ renal impairment status. The eGFR based on CKD-EPI equation will be repeated at Check-in (Day -1) to confirm renal impairment status. For matched-control healthy subjects, a single assessment of actual creatinine clearance computed over a 24-hour urine collection may be used in place of the eGFR (based on the CKD-EPI equation), at the Investigator’s (or designee’s) discretion. Subjects with severe renal impairment (Group 4), and matched-control healthy subjects with normal renal function (Group 1) will begin enrolling in the study first. Subjects will be recruited so that up to 8 subjects with severe renal impairment and up to 8 subjects with normal renal function are enrolled, with the goal of having at least 6 subjects with severe renal impairment and at least 6 matched-control healthy subjects complete the study. Subjects will be enrolled within the following groups based on their eGFR values calculated using the CKD-EPI equation10 at Screening and repeated at Check-in (Day -1) as judged by the Investigator (or designee), Covance Medical Monitor, and Sponsor: • Group 1: Matched-control healthy subjects with normal renal function (eGFR: ≥ 90 mL/min/1.73 m2) • Group 4: Subjects with severe renal impairm...
Overall Study Design and Plan. This is a double-blind, randomized, placebo-controlled, multicenter, 3 arm parallel Phase 2 study. Men and women with a current diagnosis of CM according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) and who meet the study entry criteria will enter a Screening Period followed by a Run-in Period. A Run-in Period is a prospective baseline observation in which patient’s migraine/headache activity will be recorded for at least 28 days. At the end of the Run-in Period, eligible patients will be randomized at a 1:1:1 ratio, to one of the 3 treatment arms: TNX-1900 at a fixed daily dose of 30 IU QAM / placebo QPM (Treatment Arm A), or fixed daily dose of 30 IU QAM / 30 IU QPM (Treatment Arm B), or placebo QAM / placebo QPM (Treatment Arm C), for the duration of a 12-week Treatment Period. Randomization will be stratified by study site and preventive migraine medication (use of a single preventative vs. no preventative). All participants will administer study drug twice a day, mornings and evenings, in a double-blind design. Two vials of study drug are dispensed at each dispensing visit, one clearly marked for “
Overall Study Design and Plan. This is a first-in-human, multi-center, open-label clinical study with separate Dose Escalation and Expansion Phases to assess preliminary safety, tolerability, and efficacy of KPT-9274, a dual inhibitor of PAK4 and NAMPT in patients with advanced solid malignancies or NHL for which all standard therapeutic options considered useful by the investigator have been exhausted and with progressive disease on study entry. The Dose Escalation Phase will include two parts, Part A and Part B. Patients will be enrolled according to their NAPRT1 status at a ratio of 2:1 (NAPRT1 negative:NAPRT1 positive). The NAPRT1 status must be determined prior to enrollment. For the purposes of dose escalation decisions, a standard 3+3 dose escalation design will be used during both Part A and Part B. • Part A will be performed to determine the RP2D and MTD of KPT-9274 alone (note that the RP2D may be ≤ the MTD and will be used for the Dose Expansion Phase of the study). • Part B will be performed to determine the RP2D and MTD of KPT-9274 co- administered with 500 mg up to 2,000 mg niacin ER; the starting dose of KPT-9274 for Part B will be a dose and schedule that has cleared DLT assessment during Part A.
Overall Study Design and Plan