The purpose of the study is to investigate to what extent G1T28-1 is tolerated. It will also be investigated how quickly and to what extent G1T28-1 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, a possible…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assess the safety and tolerability of G1T28-1 administered IV.
Secondary outcome
Assess the pharmacokinetic (PK) profile of G1T28-1
Assess potential pharmacodynamic (PD) markers of G1T28-1
Define G1T28-1 dose(s) for further study
Assess the bioavailability of orally administered G1T28-1 in a separate cohort
of subjects
Background summary
G1T28-1 is a new investigational compound that may eventually be used for the
prevention of chemotherapy-induced suppression of bone marrow cells. G1T28-1
will temporally block a protein that is responsible for the proliferation of
bone marrow cells producing red and white blood cells. By blocking this
protein, G1T28-1 will protect the bone marrow cells from chemotherapy and
therefore some side effects like infection, bleeding or fatigue of chemotherapy
may be reduced. This is the first time that this compound is being given to
humans.
Study objective
The purpose of the study is to investigate to what extent G1T28-1 is tolerated.
It will also be investigated how quickly and to what extent G1T28-1 is absorbed
and eliminated from the body (this is called pharmacokinetics). In addition, a
possible effect of the compound on certain blood markers will be investigated
(this is called pharmacodynamics).
The goals for analyzing the bone marrow in the current study are to:
* Provide critical pharmacodynamic (PD) information on the extent and duration
of G0/G1
arrest of HSPCs following G1T28-1 administration.
* Correlate findings in the bone marrow with surrogate assays carried out in the
peripheral blood
* Correlate PD findings in the bone marrow with pharmacokinetic (PK) data to
develop
exposure-response (PK/PD) relationships of the effects of G1T28-1 in the bone
marrow.
Study design
The study will consist of 1 dosing period during which the volunteer will
receive G1T28-1 or placebo one time for Groups 1 to 6. In Group 7 only G1T28-1
will be administered. G1T28 1 and placebo will be given in the form of an
intravenous infusion of 30 minutes.
Group 8: The actual study will consist of 3 periods. Each period you will stay
in the clinical research center in Groningen for 5 days (4 nights) and each
period will be followed by 2 days (Days 7 and 10) during which you will visit
the clinical research center in Groningen. The time interval between the
different periods is 3 days.
Intervention
Single and single-dose period G1T28-1 or placebo by intravenous infusion.
Study burden and risks
During the investigation, various assessments will be done that can be
experienced as more or less stressfull.
Blood draw, intravenous infusion and for group 7 the decrease of bone marrow
can be experienced as stressfull in this respect.
T.W. Alexander Drive 79
Research Triangle Park NC 27709
US
T.W. Alexander Drive 79
Research Triangle Park NC 27709
US
Listed location countries
Age
Inclusion criteria
healthy male or female
age 18 - 60 jaar, inclusive
BMI 18 - 32 kilogram/meter2
non smokers
Exclusion criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 3 months from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR201400238015-NL |
| CCMO | NL50159.056.14 |