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Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers

NCT ID: NCT01952548

Last Updated: 2013-12-31

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

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Brief Summary

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This study will test single doses of the study drug in increasing amounts to see if it is safe.

Detailed Description

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Conditions

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Safety and Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dose 1 Active

Group Type EXPERIMENTAL

K-312

Intervention Type DRUG

Dose 2 Active

Group Type EXPERIMENTAL

K-312

Intervention Type DRUG

Dose 3 Active

Group Type EXPERIMENTAL

K-312

Intervention Type DRUG

Dose 4 Active

Group Type EXPERIMENTAL

K-312

Intervention Type DRUG

Dose 5 Active

Group Type EXPERIMENTAL

K-312

Intervention Type DRUG

Dose 6 Active

Group Type EXPERIMENTAL

K-312

Intervention Type DRUG

Dose 7 Active

Group Type EXPERIMENTAL

K-312

Intervention Type DRUG

Dose 1 Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose 2 Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose 3 Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose 4 Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose 5 Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose 6 Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose 7 Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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K-312

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is a healthy adult male or a female of non-childbearing potential between the ages of 18 and 45 years, inclusive.
* Subject has a body mass index of 18.5 to 32 kg/m2, inclusive.

Exclusion Criteria

* Subject is a woman who is of childbearing potential or is breastfeeding.
* Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kowa Research Institute, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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K-312-1.01US

Identifier Type: -

Identifier Source: org_study_id