Healthy
Conditions
Keywords
TD-5202, 0177, single ascending dose, SAD, multiple ascending dose, MAD, first-in-human, Phase 1
Brief summary
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy subjects and Part B is a multiple ascending dose (MAD) study in healthy subjects.
Interventions
DRUGTD-5202
Study Drug to be administered orally
DRUGPlacebo
Placebo to be administered orally
Sponsors
Theravance Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, 19 - 55 years old * Willing and able to give informed consent and comply with the study * Medically healthy with no clinically significant medical history * Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg * Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method * Males must use acceptable contraception * Additional inclusion criteria apply
Exclusion criteria
* Positive for hepatitis A, B or C, HIV or tuberculosis * Clinically significant abnormalities of laboratory evaluations * Have abnormal ECG or vital sign measurements * Any acute illness at time of screening * Have a current bacterial, parasitic, fungal or viral infection * Uses or have used tobacco or nicotine-containing products within 6 months prior to screening * Additional inclusion criteria apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and tolerability of SAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events | Day 1 through Day 8 | — |
| To assess the safety and tolerability of MAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events | Day 1 through Day 17 | — |
| Pharmacokinetics (PK) of TD-5202 when given as an SAD: AUC | Day 1 through Day 4 | Area under the plasma concentration-time curve (AUC) |
| Pharmacokinetics (PK) of TD-5202 when given as a SAD: Cmax | Day 1 through Day 4 | Maximum observed concentration (Cmax) |
| Pharmacokinetics (PK) of TD-5202 when given as a SAD: Tmax | Day 1 through Day 4 | Time to reach maximum observed concentration (Tmax) |
| PK of TD-5202 when given as an SAD: CL/F | Day 1 through Day 4 | Oral Clearance (CL/F) |
| PK of TD-5202 when given as an SAD: Vz/F | Day 1 through Day 4 | Terminal Phase Volume of Distribution(Vz/F) |
| PK of TD-5202 when given as an SAD: Kel | Day 1 through Day 4 | Elimination Rate (Kel) |
| PK of TD-5202 when given as an SAD: t 1/2 | Day 1 through Day 4 | Halflife (t 1/2) |
| PK of TD-5202 when given as an MAD: AUC | Day 1 and Day 10 | Area under the plasma concentration-time curve (AUC) |
| PK of TD-5202 when given as an MAD: Cmax | Day 1 and Day 10 | Maximum observed concentration (Cmax) |
| PK of TD-5202 when given as an MAD: Tmax | Day 1 and Day 10 | Time to reach maximum observed concentration (Tmax) |
| PK of TD-5202 when given as an MAD: C trough | Day 2, 4, 6, 8 | concentration at trough (after multiple dosing usually after reaching steady state) (C trough) |
| PK of TD-5202 when given as an MAD: Css | Day 10 | concentration at steady state (Css) |
| PK of TD-5202 when given as an MAD: CL/Fss | Day 10 | Oral clearance at steady state (CL/Fss) |
| PK of TD-5202 when given as an MAD: Cmin | Day 10 | Concentration minimum (after single dosing) (Cmin) |
| PK of TD-5202 when given as an MAD: Vz/Fss | Day 10 | Terminal phase volume of distribution at steady state (Vz/Fss) |
| PK of TD-5202 when given as an MAD: Kel | Day 10 | Elimination Rate (Kel) |
| PK of TD-5202 when given as an MAD: t 1/2 | Day 10 | Halflife (t 1/2) |
Countries
United States
Outcome results
None listed