A Study In Healthy People Of Multiple Doses Of UK-396,082 Given By Mouth, To Investigate The Safety, Toleration And Time Course Of Blood Concentration Of UK-396,082 And Its Effects.

NCT01091532 | Completed Phase 1

• 1 other identifier: A3941010
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study in healthy people is to investigate the safety, toleration and time course of UK-396,082 concentration in the blood and any changes in relevant markers of drug effects, following multiple doses given twice daily by mouth for 14 days.

Conditions

Phase 1; Multiple Dose; Safety; Toleration; Pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.

  14 days

Secondary Outcomes (2)

• Plasma pharmacokinetics: Cmax, Tmax, AUCtau, t½, Rac (=AUCtau (Day 14)/AUCtau (Day 1)), CL/F, Vz/f, Cmin, Cav Urine pharmacokinetics: Aetau & Aetau%, CLR on Day 14

  14 days

• Time course of changes in prothrombin time, activated partial thromboplastin time, TAFi inhibition, fibrinogen and D-dimer concentrations.

  14 days

Study Arms (4)

Cohort 1

EXPERIMENTAL

Subjects will be assigned to receive either UK-396,082 or placebo

Drug: UK-396,082; Drug: placebo

Cohort 2

EXPERIMENTAL

Subjects will be assigned to receive either UK-396,082 or placebo

Drug: UK-396,082; Drug: placebo

Cohort 3

EXPERIMENTAL

Subjects will be assigned to receive either UK-396,082 or placebo

Drug: UK-396,082; Drug: placebo

Cohort 4

EXPERIMENTAL

Subjects will be assigned to receive either UK-396,082 or placebo

Drug: UK-396,082; Drug: placebo

Interventions

UK-396,082 DRUG

100mg given orally twice daily for 14 days The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose.

Cohort 1

placebo DRUG

given orally twice daily for 14 days

Cohort 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• A positive urine drug screen.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

5-amino-2-((1-n-propyl-1H-imidazol-4-yl)methyl)pentanoic acid

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 24, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 4, 2018

Record last verified: 2018-11

Locations

BE (1)