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

NCT02471859 | Completed Phase 1

• 2 other identifiers: GB297512015-000560-33
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Number of participants experiencing an adverse event

  Up to approximately 6 months

Secondary Outcomes (6)

• Maximum concentration (Cmax) for GDC-3280

  Up to 4 days

• Time to Cmax (Tmax) for GDC-3280

  Up to 4 days

• Total serum clearance for GDC-3280

  Up to 4 days

• Volume of distribution for GDC-3280

  Up to 4 days

• Elimination half-life for GDC-3280

  Up to 4 days

Study Arms (4)

Part A: GDC-3280

EXPERIMENTAL

Participants in multiple cohorts and treatment periods will receive single doses of GDC-3280 under fed/fasting conditions.

Drug: GDC-3280

Part A: Placebo

PLACEBO COMPARATOR

Participants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions.

Drug: Placebo

Part B: GCD-3280

EXPERIMENTAL

Participants in different cohorts will receive GDC-3280 in multiple ascending doses under fed/fasting conditions.\\n

Drug: GDC-3280

Part B: Placebo

PLACEBO COMPARATOR

Participants in different cohorts will receive placebo in multiple ascending doses under fed/fasting conditions.\\n

Drug: Placebo

Interventions

GDC-3280 DRUG

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

Part A: GDC-3280; Part B: GCD-3280

Placebo DRUG

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

Part A: Placebo; Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Unknown Facility

Leeds, LS2 9LH, United Kingdom

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 15, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

GB (1)