A Study of RG7625 in Healthy Volunteers

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT02295332

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single center, randomized, double-blind, placebo-controlled, single ascending dose study that will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single doses of RG7625 in healthy male and female volunteers.

The study will employ an interleaved cohort ('leapfrog') design in which dosing is alternated between two cohorts and each individual within a cohort will receive study drug dosing on four occasions - in effect giving a four treatment, four period, four-way crossover for each individual. The minimum duration for each participant is approximately 8 weeks.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: Placebo Drug: RG7625	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A	Drug: Placebo Matching oral placebo capsules to RG7625, according to treatment schedule Drug: RG7625 oral administration, capsules, single ascending dose according to treatment schedule
Experimental: Cohort B	Drug: Placebo Matching oral placebo capsules to RG7625, according to treatment schedule Drug: RG7625 oral administration, capsules, single ascending dose according to treatment schedule

Arm

Intervention/Treatment

Experimental: Cohort A

Drug: Placebo

Matching oral placebo capsules to RG7625, according to treatment schedule

Drug: RG7625

oral administration, capsules, single ascending dose according to treatment schedule

Experimental: Cohort B

Drug: Placebo

Matching oral placebo capsules to RG7625, according to treatment schedule

Drug: RG7625

oral administration, capsules, single ascending dose according to treatment schedule

Outcome Measures

Primary Outcome Measures

Safety (composite outcome measure):Incidence and severity of adverse events (AEs), laboratory abnormalities, changes in ECG, vital signs [Approximately 22 weeks]

Secondary Outcome Measures

Pharmacokinetics (composite outcome measure): PK profile and parameters derived from plasma concentrations of RG7625 and its metabolites [AUCinf, AUClast, Cmax, tmax, t1/2, CL/F, V/F, Ae, fe and CLR] [22 weeks]
Pharmacodynamics (composite outcome measure): measurement of intracellular p10 concentrations and cell surface expression of major histocompatibility complex class (MHC)-II, relationship to RG7625 exposure [22 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male and female participants, 18 to 60 years of age, inclusive
A body mass index between 18 to 30 kg/m2 inclusive
Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria:

Any clinically relevant abnormalities, concomitant diseases or ongoing medical conditions, abnormal laboratory test results or a history of any other clinically significant disorders
Any major illness within the one month preceding the screening visit, or any febrile illness within the two weeks preceding the screening visit
Any significant allergic reaction to drugs
Immunocompromised or with reduced immune function and/or immunization within 30 days before the first study drug administration or planning vaccination during the study
Women who are pregnant or lactating or of childbearing potential
Clinically significant abnormal ECG or other risk factors for QT prolongation
Use of prescribed or over the counter medication
Inability or unwillingness to comply with study requirements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Zuidlaren		Netherlands	9471 GP

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT02295332

Other Study ID Numbers:

WP29542
2014-003538-23

First Posted:

Nov 20, 2014

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Study Results

No Results Posted as of Nov 2, 2016