Healthy volunteers
Conditions
Interventions
Product Name: Maribavir
Product Code: TAK-620
Pharmaceutical Form: Tablet
Product Name: Maribavir
Product Code: TAK-620
Pharmaceutical Form: Powder for oral suspension
Product Name: Maribavir
Produc
Sponsors
Shire
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - An understanding, ability, and willingness to fully comply with study procedures and restrictions. - Ability to voluntarily provide written, signed, and dated (personally or via a legally-authorized representative) informed consent/and assent as applicable to participate in the study. - Age 18-50 years, inclusive at the time of consent. - Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential. - Healthy as determined by the investigator on the basis of screening evaluations. - Hemoglobin for males greater than or equal to (> or =)135.0 gram per liter (g/L) and females > or = 120.0 g/L at screening and on Day -1. - Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m2) inclusive with a body weight greater than (>) 50 kg (110 lbs). - Ability to swallow a dose of investigational product. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gallbladder removal, or current recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments. - Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures. - Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any of the stated ingredients. - Significant illness, as judged by the investigator, within 2 weeks of the first dose of investigational product. - Donation of blood or blood products (e.g., plasma or platelets) within 60 days prior to receiving the first dose of investigational product. - Within 30 days prior to the first dose of investigational product:a) Have used an investigational product, b) Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this study, c) Have had any substantial changes in eating habits, as assessed by the investigator. - Confirmed systolic blood pressure >139 millimetre of mercury (mmHg) or 89 mmHg or 450 millisecond (msec). - Known history of alcohol or other substance abuse within the last year. - Male participants who consume more than 21 units of alcohol per week or 3 units per day. Female participants who consume more than 14 units of alcohol per week or 2 units per day. - A positive screen for alcohol or drugs of abuse at screening or on Day -1 of Treatment Period. - A positive human immunodeficiency virus (HIV), HBsAg, or Hepatitis C virus (HCV) antibody screen. - Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch). - Routine consumption of more than 2 units of caffeine per day or participants who experience caffeine withdrawal headaches. - Prior screen failure, randomization, enrollment, participation in this study or participation in Part 1 of this study. - Current use of any prescription medication with the exception of hormonal replacement therapy. (Current use is defined as use within 30 days of the first dose of investigational product.) Current use of any over the counter medication (including herbal, or homeopathic preparations) within 14 days of the first dose of investigational product. - Current use of antacids and H2 antagonists. - Ingestion of known CYP3A modulators within 7 days of Day 1, Period 1. - Inability or unwillingness to consume 100 percent of high-fat meal in Part 2 (including participants with lactose or gluten intolerance). - History of oral/nasal cavity infections, gastroesophageal reflux, asthma treatment with albuterol, zinc supplementation. - Participants with dry mouth syndrome or burning mouth syndrome or menopausal women suffering from dysgeusia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose of this study is to assess the relative bioavailability, dose proportionality, the impact of food on the rate and extent of absorption and palatability of the selected pediatric formulation of maribavir in healthy participants.;Secondary Objective: The secondary purpose of this study is to assess the safety and tolerability of two candidate pediatric formulations and the adult tablet formulation of maribavir in healthy participants.;Primary end point(s): - Part 1: Maximum Concentration (Cmax) Occurred at Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma - Part 1: Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma - Part 1: Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of Maribavir in Plasma - Area Under the Curve Extrapolated to Infinity, Calculated Using the Observed Value of the Last Non-Zero Concentration (AUC0-Inf) of Maribavir in Plasma - Part 1: Terminal Half-Life (t1/2) of Maribavir in Plasma - Part 1: Apparent Total Body Clearance Following Extravascular Administration (CL/F) of Maribavir in Plasma - Part 1: Delay Between the Time of Dosing and Time of Appearance of Plasma Concentration (Tlag) of Maribavir in Plasma - Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7;Timepoint(s) of evaluation of this end point: Up to Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: From start of study drug administration up to follow-up (Day 17);Secondary end point(s): - Number of Participants With Treatment-Emergent Adverse Events (TEAEs) - Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs - Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs - Number of Participants With Clinically Significant Changes in Clinical Laboratory Results Reported as TEAEs | — |
Countries
United States
Contacts
Public ContactClinical Transparency
Shire
Outcome results
None listed