Repeat Dose Safety Study for Compound to Treat Anemia

NCT00840320 | Completed Phase 1

• 1 other identifier: 112842
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize the safety and tolerability of repeat doses of compound 1278863A in healthy subjects.

Conditions

Kidney Disease

Keywords

Safety; tolerability

Outcome Measures

Primary Outcomes (8)

• adverse events reporting

  throughout study

• Safety Labs (hematology)

  Screening, Days -1, 1-3, 5, 7, 9, 11, 14-18, 21, 25, 28

• vital signs (blood pressure and heart rate)

  Days 1-15, 28

• 12-lead ECG

  Screening, Days 1-2, 4, 6, 8, 10, 12, 14, 28

• dual-lead cardiac monitoring (telemetry monitoring)

  Days -1 to 3, 14

• clinical monitoring/observation

  throughout

• Safety Labs (Chemistry)

  Screening, Days -1, 1-3, 7, 10, 14-15, 17, 21, 28

• Safety Labs (Urinalysis)

  Screening, Days -1, 1-3, 7, 10, 14-15, 17, 21, 28

Secondary Outcomes (9)

• AUC(0-∞) on Day 1, AUC(0-τ), Cmax, tmax and t1/2, on Days 1 and 14

  Days 1-2, 4, 6, 8, 10, 12, 14-18

• Trough plasma concentrations at the end of the dosing interval

  Days 2, 4, 6, 8, 10 and 12

• Hemoglobin actual values, rate of rise, maximum change from baseline, and rate of decline following stopping of dosing

  Days 1, 7, 14, 21, 28

• Fetal hemoglobin actual values, change from baseline, and percent of total hemoglobin

  Days 1, 7, 14, 21, 28

• Actual values and change from baseline in erythropoietin

  Days 1-4, 7, 14-15, 18, 21

Study Arms (2)

1

EXPERIMENTAL

Repeat doses of active at escalating doses

Drug: 1278863

2

PLACEBO COMPARATOR

Repeat doses of placebo

Drug: Placebo

Interventions

1278863 DRUG

15mg, 25mg, 50mg, 150mg

1

Placebo DRUG

matching placebo

2

Eligibility Criteria

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

You may qualify if:

• Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
• Male or female between 18 and 55 years of age, inclusive.
• A female subject must be of non-childbearing potential.
• Male subjects must agree to use one of the acceptable contraception methods listed in the protocol
• Body weight greater than or equal to 50 kg and BMI within the range 19 - 31 kg/m2 (inclusive).
• Capable of giving written informed consent
• QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.

You may not qualify if:

• The subject has a positive pre-study drug screen.
• A hemoglobin value at screening is:
• Male subjects or post-menopausal females: \> 15.5 g/dL
• Female subjects: \> 14.5 g/dL
• The values of hematological parameters at screening are:
• MCV: outside the reference range and clinically significant deemed by the investigator and GSK Medical Monitor
• The values of the following tests at screening are:
• TIBC: outside the reference range
• Serum iron: outside the reference range
• Serum ferritin: outside the reference range
• A value at screening is greater than the upper limit of reference range for the following clinical laboratory parameters: AST, ALT, direct bilirubin.
• Clinically significant abnormal CPK determined by the investigator and GSK Medical Monitor.
• Calculated creatinine clearance: \< 60mL/min
• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
• A positive test for HIV antibody.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Melbourne, Victoria, 3004, Australia

Location

Related Links

• Results for study 112842 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2009
• First Posted: February 10, 2009
• Study Start: March 13, 2009
• Primary Completion: September 2, 2009
• Study Completion: September 2, 2009
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

AU (1)