A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers

Healthy Adult Subjects Clinical Trial

Official title:

A Phase 1, Single Centre, Three-part, Randomised, Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single and Multiple Ascending Doses of Oral ONO-4053 and the Effects of Food on This Profile in Healthy Male and Female Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01379586
• Other study ID #: ONO-4053POE001
• Secondary ID: Eudra CT No. 201
• Status: Terminated
• Phase: Phase 1
• First received: June 21, 2011
• Last updated: June 12, 2012
• Start date: June 2011

Study information

• Verified date: June 2012
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and tolerability of ONO-4053 across ascending single and multiple doses in healthy adult male and female subjects. The secondary objective of the study is to characterize the pharmacokinetic profile of ONO-4053 in healthy adult male and female subjects.

Description:

This is a first-in-human study of ONO-4053 in healthy volunteers. This study consists of three parts. Part A will investigate the safety, tolerability and pharmacokinetics when single ascending doses of ONO-4053 are administered in a double-blind manner. Part B will investigate the pharmacokinetics of ONO-4053 in the fed and fasted state in an open-label manner. Part C will investigate the safety, tolerability and pharmacokinetics when multiple ascending doses of ONO-4053 are administered in a double-blind manner. Doses for Part B and C will be determined after data from Part A are available.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy caucasian subjects aged 18-45 years inclusive

• Subjects with a body mass index of 19-30 kg/m2 inclusive and who weigh at least 50 kg and no more than 100 kg at screening.

Exclusion Criteria:

• Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder.

• Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Drug:
• ONO-4053
Part A: ONO-4053 doses proposed are 1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 300 mg, 600 mg as a single dose administered by mouth once daily
• Placebo
Placebo to match ONO-4053 tablets dosed in a similar manner to ONO-4053

Locations

Country	Name	City	State
United Kingdom	Leeds Clinical Site	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of ONO-4053 across ascending single and multiple doses using adverse events, vital signs, 12-lead ECG, continuous ECG monitoring and clinical lab tests.		At protocol-specified timepoints before and after study drug administration up to Day 14	Yes
Secondary	Plasma and urine concentrations of ONO-4053 and derived pharmacokinetic parameters		At protocol-specified timepoints before and after study drug administration up to Day 14	No