A Study to Evaluate the Dose-proportionality and Effects of FG-4592 in Healthy Young and Elderly Male and Female Subjects

NCT02161796 | Completed Phase 1

• 2 other identifiers: 1517-CL-05252013-001044-57
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the concentration of FG-4592 in the blood over a certain period after the intake of different doses, and assesses the effects, the safety and the tolerability of the study drug in healthy young and elderly male and female subjects. On Day 1 of each of 4 periods subjects receive different single doses of FG-4592 or a placebo, depending on the treatment sequence to which they are randomized. For each period the subjects remain in the clinic for 6 days (Days -2 to 4). They are discharged after all assessments are completed on Day 4 of each period, and return for an End of Study visit (ESV) between 5 and 9 days after the last assessment of Period 4.

Conditions

PK for FG-4592; Healthy Subjects

Keywords

Phase 1; FG-4592; Age/gender comparison

Outcome Measures

Primary Outcomes (2)

• PK after a single dose of FG-4592 measured by area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf),

  Days 1- 4 (all periods)

• PK after a single dose of FG-4592 measured by maximum concentration (Cmax)

  Days 1- 4 (all periods)

Secondary Outcomes (4)

• PK of FG-4592 in plasma

  Days 1 - 4 (all periods)

• PK of FG-4592 in urine

  Days 1 - 4 (all periods)

• Plasma concentration of EPO, VEGF, reticulocytes and hepcidin

  Days 1 - 4 (all periods)

• Safety and tolerability of a single dose FG-4592

  Screening to ESV (5-9 days after the last assessment of Period 4 (or after early withdrawal))

Study Arms (4)

1: young male subjects

EXPERIMENTAL

3x single dose of FG-4592 and a placebo

Drug: FG-4592; Drug: Placebo

2: young female subjects

EXPERIMENTAL

3x single dose of FG-4592 and a placebo

Drug: FG-4592; Drug: Placebo

3: elderly male subjects

EXPERIMENTAL

3x single dose of FG-4592 and a placebo

Drug: FG-4592; Drug: Placebo

4: elderly female subjects

EXPERIMENTAL

3x single dose of FG-4592 and a placebo

Drug: FG-4592; Drug: Placebo

Interventions

FG-4592 DRUG

Oral

Also known as: ASP1517,, roxadustat

1: young male subjects; 2: young female subjects; 3: elderly male subjects; 4: elderly female subjects

Placebo DRUG

Oral

1: young male subjects; 2: young female subjects; 3: elderly male subjects; 4: elderly female subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• YOUNG: Subject is a healthy young male or a healthy female subject aged 18 to 45 years of age inclusive
• ELDERLY: Subject is a healthy elderly male or female subject aged 65 or above
• Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control
• Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration
• Female subject must be either of non-childbearing potential or, if of childbearing potential, must have a negative pregnancy test at screening and Day -2 and must use 2 forms of birth control
• Female subject must not be breastfeeding at screening or during the study period and for 28 days after the final study drug administration
• Female subject must not donate ova starting at screening and throughout the study period and for 28 days after the final study drug administration

You may not qualify if:

• Female subject who has been pregnant within 6 months before screening or breastfeeding within 3 months before screening
• Subject used grapefruit, grapefruit juice (more than 3 x 200 mL) or orange marmalade (more than 3 times) in the week prior to admission to the clinic until ESV
• The subject is a vulnerable subject

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead
• Kyntra Bio: collaborator

Study Sites (1)

Parexel International GmbH

Berlin, 14050, Germany

Location

MeSH Terms

Interventions

roxadustat

Study Officials

• Central Contact

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 12, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 12, 2014

Record last verified: 2014-06

Locations

DE (1)