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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: GDC-3280

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

Group Type EXPERIMENTAL

GDC-3280

Intervention Type DRUG

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

Part A: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Part B: GCD-3280

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

Group Type EXPERIMENTAL

GDC-3280

Intervention Type DRUG

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

Part B: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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GDC-3280

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes