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

Healthy Volunteer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471859
• Other study ID #: GB29751
• Secondary ID: 2015-000560-33
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2015
• Last updated: March 15, 2016
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• GDC-3280
GDC-3280 at various doses, depending on the cohort and treatment period
• Placebo
Placebo at various doses, depending on the cohort and treatment period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing an adverse event		Up to approximately 6 months	No
Secondary	Maximum concentration (Cmax) for GDC-3280		Up to 4 days	No
Secondary	Time to Cmax (Tmax) for GDC-3280		Up to 4 days	No
Secondary	Total serum clearance for GDC-3280		Up to 4 days	No
Secondary	Volume of distribution for GDC-3280		Up to 4 days	No
Secondary	Elimination half-life for GDC-3280		Up to 4 days	No
Secondary	Serum GDC-3280 concentration-time data by dosing group		Up to 4 days	No