Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935

Dose-finding Study Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single Doses of TAK-935 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201056
• Other study ID #: TAK-935_101
• Secondary ID: U111-1155-6022
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2014
• Last updated: September 16, 2015
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels.

Description:

The drug being tested in this study is TAK-935. TAK-935 is being tested to find a safe and well-tolerated dose and to assess how TAK-935 is processed by the body. This study will look at side effects and lab results in people who take TAK-935 and is designed as a randomized dose-rising study.

The study will consist of 6 Cohorts with 8 participants in each Cohort. In each Cohort, 6 participants will receive a single dose of TAK-935 and 2 participants will receive placebo after a 10-hour fast. The starting dose will be 15 mg followed by planned doses of 50, 200, 600, 900 and not to exceed 1350 mg in subsequent cohorts.

This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 46 days. Participants will make 2 visits to the clinic, including one 7-day period of confinement to the clinic. All participants will be contacted by telephone 14 days after the dose of study drug for a follow-up assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time of informed consent.

2. Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive at the Screening Visit.

Exclusion Criteria:

1. Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.

2. Has a known hypersensitivity to any component of the formulation of TAK-935.

3. There is any finding in the participant's medical history, significant results from physical examination, or safety laboratory tests.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dose-finding Study

Intervention

Drug:
• TAK-935
TAK-935 oral solution
• Placebo
TAK-935 placebo-matching oral solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who experience at least 1 treatment-emergent adverse event	An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.	Day 1 to Day 14	No
Primary	Percentage of participants who meet the pre-specified markedly abnormal criteria, as defined in the protocol, for safety laboratory tests at least once post-dose	The percentage of participants with any markedly abnormal, according to Takeda criteria, standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.	Day 1 to Day 14	No
Primary	Percentage of participants who meet the pre-specified markedly abnormal criteria, as defined in the protocol, for vital sign measurements at least once post-dose	The percentage of participants with any markedly markedly abnormal, according to Takeda criteria, vital signs, including oral temperature, respiration rate, pulse, and blood pressure, during the treatment period.	Day 1 to Day 14	No
Primary	Percentage of participants who meet the pre-specified markedly abnormal criteria, as defined in the protocol, for electrocardiogram measurements at least once post-dose	The percentage of participants with any markedly abnormal, according to Takeda criteria, electrocardiogram measurements during the treatment period.	Day 1 to Day 14	No
Secondary	Maximum observed plasma concentration (Cmax) of TAK-935	Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.	Days 1 through 5	No
Secondary	Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUCt) of TAK-935	The area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUCt) of TAK-935 will be determined from the concentration-time curve.	Days 1 through 5	No
Secondary	Area under the plasma concentration-time curve from time 0 to infinity (AUC8) of TAK-935	The area under the plasma concentration-time curve from time 0 to infinity (AUC8) of TAK-935 will be determined from the concentration-time curve.	Days 1 through 5	No