Effects of CS-8080 in Healthy Volunteers

NCT00613431 | Completed Phase 1

• 1 other identifier: CS8080-A-U101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The main purposes of this study are to assess the safety and measure the pharmacokinetics of CS-8080 in healthy volunteers.

Conditions

Healthy

Keywords

pharmacodynamics

Outcome Measures

Primary Outcomes (2)

• Safety assessed over the 5-day post-dose inpatient period and at a follow-up 1 week post-discharge.

  2 weeks

• Single dose plasma pharmacokinetics of CS-8080

  2 weeks

Secondary Outcomes (1)

• Pharmacodynamic response to CS-8080, as assessed by mRNA levels to 24 h post-dose.

  2 weeks

Study Arms (2)

1

EXPERIMENTAL

6 dose groups, 9 subjects on active, 3 subjects on placebo in each group

Drug: CS8080

2

PLACEBO COMPARATOR

3 subjects on placebo in each group

Drug: Placebo

Interventions

CS8080 DRUG

CS-8080 tablets will be administered once daily at doses of 1, 3, 10, 20, 50 and 100 mg.

1

Placebo DRUG

Some subjects will receive matching placebo instead of CS-8080.

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women must be of non-child bearing potential, ie, either:Surgically sterile (ie, bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing), or Naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to dosing, with an FSH level at screening of \> 40 mIU/mL.
• All women must have a negative serum pregnancy test at screening and within 48 hours before dosing.
• Body Mass Index (BMI) of 19 to 30 kg/m2 inclusive.
• Good health as determined by the absence of clinically significant deviation from normal, based on medical history, physical examination, laboratory reports, and 12 lead ECG, as deemed by the Investigator, prior to enrollment.
• Able to understand and willing to comply with all study requirements, and willing to follow the study medication regimen.
• Willing and able to give a written informed consent.
• Negative urine test for drugs of abuse and alcohol at screening and check-in.
• Negative result for HIV antibody, hepatitis B surface antigen, and hepatitis C antibody at screening.

You may not qualify if:

• Any history of drug abuse.
• History of alcohol addiction during the 2 years prior to Day 1.
• History of significant allergic response to any drug except penicillin.
• History or current evidence, as determined by the Investigator, of psychiatric or emotional problems which would invalidate giving informed consent or limit the ability of the subject to comply with study requirements.
• History or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine, neurologic, infectious, gastrointestinal (ie, any condition which may affect drug absorption), hematologic, or oncologic disease as determined by the Investigator after reviewing screening history, physical examination, laboratory test results, and 12-lead ECG.
• History or current alcoholic or non-alcoholic liver disease or liver steatosis.
• History of prostate disease or prostatitis.
• Subjects with a history of congenital Long QT Syndrome (LQTS), a history of surviving a near-drowning episode, or a history of any form of syncope or loss of consciousness.
• Subjects with QTc interval duration \>450 msec obtained as an average from the ECG machine readings on the triplicate ECG (3 readings in rapid succession and not more than 2 minutes apart) taken at screening, after at least 10 minutes of quiet rest in a supine position.
• Subjects with abnormal ECG waveform morphology on any of the ECGs from the screening triplicate that would preclude accurate manual measurement of the QT interval duration.
• Need for any concomitant medication.
• Prestudy medication use as specified in Section 6.2.1.
• Consumption of any food or beverages containing grapefruit from 7 days prior to Day 1 through study completion.
• Consumption of foods or beverages containing alcohol from 24 hours before check-in through discharge from the clinic.
• Blood donation or significant blood loss within the 56 days before Day -1.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

MDS Pharma Services

Neptune City, New Jersey, 07753, United States

Location

Study Officials

• Robert Noveck, MD

  MDS Pharma Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: January 1, 2008
• Primary Completion: August 1, 2008
• Last Updated: December 21, 2018

Record last verified: 2008-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

US (1)