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Completed

NCT Number: NCT04044339

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

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.

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Theravance Biopharma Investigational Site

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TD-5202

Drug

Study Drug to be administered orally

Placebo

Drug

Placebo to be administered orally

Primary outcomes

  1. 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

  2. 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

  3. 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)

  4. Pharmacokinetics (PK) of TD-5202 when given as a SAD: Cmax

    Time frame: Day 1 through Day 4

    Maximum observed concentration (Cmax)

  5. 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)

  6. PK of TD-5202 when given as an SAD: CL/F

    Time frame: Day 1 through Day 4

    Oral Clearance (CL/F)

  7. 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)

  8. PK of TD-5202 when given as an SAD: Kel

    Time frame: Day 1 through Day 4

    Elimination Rate (Kel)

  9. PK of TD-5202 when given as an SAD: t 1/2

    Time frame: Day 1 through Day 4

    Halflife (t 1/2)

  10. 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)

  11. PK of TD-5202 when given as an MAD: Cmax

    Time frame: Day 1 and Day 10

    Maximum observed concentration (Cmax)

  12. PK of TD-5202 when given as an MAD: Tmax

    Time frame: Day 1 and Day 10

    Time to reach maximum observed concentration (Tmax)

  13. 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)

  14. PK of TD-5202 when given as an MAD: Css

    Time frame: Day 10

    concentration at steady state (Css)

  15. PK of TD-5202 when given as an MAD: CL/Fss

    Time frame: Day 10

    Oral clearance at steady state (CL/Fss)

  16. PK of TD-5202 when given as an MAD: Cmin

    Time frame: Day 10

    Concentration minimum (after single dosing) (Cmin)

  17. 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)

  18. PK of TD-5202 when given as an MAD: Kel

    Time frame: Day 10

    Elimination Rate (Kel)

  19. PK of TD-5202 when given as an MAD: t 1/2

    Time frame: Day 10

    Halflife (t 1/2)

Sponsors and collaborators

Lead sponsor

Theravance Biopharma

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 5, 2019
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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