Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects

Overview

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.

Full Title of Study: “A Double-blind, Randomized, Placebo-controlled, Sponsor-open, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-5202 in Healthy Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: November 27, 2019

Interventions

  • Drug: TD-5202
    • Study Drug to be administered orally
  • Drug: Placebo
    • Placebo to be administered orally

Arms, Groups and Cohorts

  • Experimental: TD-5202 for SAD (Part A)
    • 6 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive TD-5202
  • Placebo Comparator: Placebo for SAD (Part A)
    • 2 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive placebo
  • Experimental: TD-5202 for MAD (Part B)
    • 6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-5202
  • Placebo Comparator: Placebo for MAD (Part B)
    • 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo.

Clinical Trial Outcome Measures

Primary Measures

  • To assess the safety and tolerability of SAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events
    • Time Frame: 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
    • Time Frame: Day 1 through Day 17
  • Pharmacokinetics (PK) of TD-5202 when given as an SAD: AUC
    • Time Frame: Day 1 through Day 4
    • Area under the plasma concentration-time curve (AUC)
  • Pharmacokinetics (PK) of TD-5202 when given as a SAD: Cmax
    • Time Frame: Day 1 through Day 4
    • Maximum observed concentration (Cmax)
  • Pharmacokinetics (PK) of TD-5202 when given as a SAD: Tmax
    • Time Frame: Day 1 through Day 4
    • Time to reach maximum observed concentration (Tmax)
  • PK of TD-5202 when given as an SAD: CL/F
    • Time Frame: Day 1 through Day 4
    • Oral Clearance (CL/F)
  • PK of TD-5202 when given as an SAD: Vz/F
    • Time Frame: Day 1 through Day 4
    • Terminal Phase Volume of Distribution(Vz/F)
  • PK of TD-5202 when given as an SAD: Kel
    • Time Frame: Day 1 through Day 4
    • Elimination Rate (Kel)
  • PK of TD-5202 when given as an SAD: t 1/2
    • Time Frame: Day 1 through Day 4
    • Halflife (t 1/2)
  • PK of TD-5202 when given as an MAD: AUC
    • Time Frame: Day 1 and Day 10
    • Area under the plasma concentration-time curve (AUC)
  • PK of TD-5202 when given as an MAD: Cmax
    • Time Frame: Day 1 and Day 10
    • Maximum observed concentration (Cmax)
  • PK of TD-5202 when given as an MAD: Tmax
    • Time Frame: Day 1 and Day 10
    • Time to reach maximum observed concentration (Tmax)
  • PK of TD-5202 when given as an MAD: C trough
    • Time Frame: 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
    • Time Frame: Day 10
    • concentration at steady state (Css)
  • PK of TD-5202 when given as an MAD: CL/Fss
    • Time Frame: Day 10
    • Oral clearance at steady state (CL/Fss)
  • PK of TD-5202 when given as an MAD: Cmin
    • Time Frame: Day 10
    • Concentration minimum (after single dosing) (Cmin)
  • PK of TD-5202 when given as an MAD: Vz/Fss
    • Time Frame: Day 10
    • Terminal phase volume of distribution at steady state (Vz/Fss)
  • PK of TD-5202 when given as an MAD: Kel
    • Time Frame: Day 10
    • Elimination Rate (Kel)
  • PK of TD-5202 when given as an MAD: t 1/2
    • Time Frame: Day 10
    • Halflife (t 1/2)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Theravance Biopharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Theravance Biopharma

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