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

Kowa

Status and phase: Completed; Phase 1

Conditions: Safety and Tolerability

Treatments: Drug: Placebo; Drug: K-312

Study type: Interventional

Funder types: Industry

Identifiers

NCT01952548

K-312-1.01US

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 14 patient groups, including a placebo group

Dose 1 Active

Experimental group

Treatment:

Drug: K-312

Dose 2 Active

Experimental group

Treatment:

Drug: K-312

Dose 3 Active

Experimental group

Treatment:

Drug: K-312

Dose 4 Active

Experimental group

Treatment:

Drug: K-312

Dose 5 Active

Experimental group

Treatment:

Drug: K-312

Dose 6 Active

Experimental group

Treatment:

Drug: K-312

Dose 7 Active

Experimental group

Treatment:

Drug: K-312

Dose 1 Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Dose 2 Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Dose 3 Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Dose 4 Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Dose 5 Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Dose 6 Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Dose 7 Placebo

Placebo Comparator group

Treatment:

Drug: Placebo