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OpenTrials
Completed

NCT Number: NCT02471859

A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Participants

This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Is male or female, using highly effective contraception
  • Has a body mass index (BMI) 18.0 to 30.0 kg/m2, inclusive
  • Is in good general health
  • Having signed informed consent, is willing and able to comply with requirements of the study

Exclusion criteria

  • Does not satisfy all screening criteria per protocol
  • Is employed by or related to any personnel involved in the trial
  • Has any history or condition that per protocol or in the opinion of the investigator could compromise the participant's safety or analysis of results

Treatment and study plan

GDC-3280

Drug

GDC-3280 at various doses, depending on the cohort and treatment period

Placebo

Drug

Placebo at various doses, depending on the cohort and treatment period

Primary outcomes

  1. Number of participants experiencing an adverse event

    Time frame: Up to approximately 6 months

Secondary outcomes

  1. Maximum concentration (Cmax) for GDC-3280

    Time frame: Up to 4 days

  2. Time to Cmax (Tmax) for GDC-3280

    Time frame: Up to 4 days

  3. Total serum clearance for GDC-3280

    Time frame: Up to 4 days

  4. Volume of distribution for GDC-3280

    Time frame: Up to 4 days

  5. Elimination half-life for GDC-3280

    Time frame: Up to 4 days

  6. Serum GDC-3280 concentration-time data by dosing group

    Time frame: Up to 4 days

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 15, 2015
Registry last updated
Mar 17, 2016

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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