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Pharmacokinetics of ASP1707Phase 1NCT02368912

A Study to Assess the Safety, Tolerability and Effects of Single and Multiple Ascending Doses of ASP1707 in Healthy Male and Pre-menopausal Female Subjects, Including a Comparison of the Effects Under Fasted and Fed Conditions in Healthy Young Male Subjects

A Phase 1 study testing ASP1707 single dose of dose levels 1 -7, ASP1707 single dose fasted and ASP1707 single dose fed in people with Pharmacokinetics of ASP1707 and Pharmacodynamics of ASP1707, run by Astellas Pharma Europe B.V. at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study consists of four parts: Part 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy young male subjects to evaluate the safety, tolerability pharmacokinetics (PK) and effect on certain hormones and if possible to determine the highest well-tolerated dose of ASP1707 in… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
ASP1707 single dose of dose levels 1 -7, ASP1707 single dose fasted and ASP1707 single dose fed
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
176 participants
Where
1 siteFrance
Study dates
Jun 2010to Aug 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Parts 1 \& 2:
  • Healthy young male subject aged 18 to 45 years inclusive
  • Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
  • Male subjects must be non-fertile, or must practice an adequate contraceptive method to prevent pregnancies.
  • Part 3:
  • Healthy elderly male subject aged 55 years or older, or healthy pre-menopausal female subject aged 18 to 45 inclusive.
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  • Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
  • Male subject must be non-fertile, or must practice adequate contraceptive methods.
  • Female subjects must be of non-child bearing potential, i.e. surgically sterilized or practice adequate (double barrier) non-hormonal contraceptive methods.
  • Part 4:
  • Healthy pre-menopausal female subject aged 18 to 45 inclusive.
  • Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
  • Female subjects must be of non-child bearing potential, i.e. surgically sterilized or practice adequate contraceptive methods.
  • Females having a regular menstruation cycle with a duration between 25 up to 30 days.

Who cannot join

  • Parts 1 \& 2:
  • Male subjects with out-of-range Testosterone levels in serum at screening.
  • Subjects with any history of cancer.
  • Any of the liver function tests (i.e. ALT and AST) above the upper limit of normal.
  • A QTc interval of > 430 ms after repeated measurements.
  • Regular use of any inducer of metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.
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  • Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.
  • Part 3:
  • Pregnancy within 6 months before screening assessment or breast feeding 3 months before screening.
  • Male subjects with out-of-range T levels in serum at screening.
  • Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.
  • Part 4:
  • Pregnancy within 6 months before screening assessment or breast feeding 3 months before screening.
  • Use of any hormonal interfering contraceptives in the 3 months before admission (for 3 consecutive menstruation cycles) OR any evidence of unovulatory menstrual cycles.
  • Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.

Trial locations and contacts

1 site in 1 country.

France1 site

  • SGS Life Science Services, Aster

    Paris, 75015

Other trials in France

About this study

Official title: A Double Blind, Randomized, Placebo-controlled, Ascending Single and Multiple Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1707 in Healthy Young and Elderly Male Subjects and in Healthy Pre-menopausal Female Subjects Including an Open-label Comparison of Pharmacokinetics Under Fasted and Fed Conditions in Healthy Young Male Subjects

This study consists of four parts:

Part 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy young male subjects to evaluate the safety, tolerability pharmacokinetics (PK) and effect on certain hormones and if possible to determine the highest well-tolerated dose of ASP1707 in healthy young male subjects under fasted conditions.

Read more

Part 2 is an open label, randomized crossover, single dose study to determine the effect of food on the pharmacokinetics of ASP1707and effect on certain hormones in healthy young male subjects.

Part 3 is a randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetics (PK) of ASP1707 in healthy elderly men and healthy premenopausal females, and to determine the effect on certain hormones in males. Age and gender is also evaluated.

Part 4 is a randomized, double-blind, placebo-controlled, parallel, multiple dose study to evaluate the safety, tolerability and PK of ASP1707, and its effect on certain hormones in healthy pre-menopausal female subjects.

Read the detailed description

Part 1 comprises 7 dose groups of 8 healthy young male subjects. ASP1707 or matching placebo ( 3 to 1 ratio) is given as a single dose under fasted conditions.

The first group receives the lowest dose while the last group receives the highest dose.

Part 2 (Food-Effect) The group consists of 12 healthy young male subjects who receive two separate doses of ASP1707 under fasted or fed conditions. Half of the subjects are dosed first under fasted condition and half of them had first an FDA high-fat breakfast. Subjects receive the alternate treatment on the second occasion. Dosing is separated by at least 7 days or 7 times t1/2 (terminal elimination half-life) as assessed from Part 1.

Part 3 Comprises 4 dose groups of 12 healthy elderly men each, and two groups of 12 healthy premenopausal women. The latter are dosed ASP1707 or placebo in parallel to the 4 male groups. Subjects are fasted or fed depending on observations from Part 2.

Dose levels are defined after evaluating interim safety, tolerability and PK and PD results from Part 1. A lower maximum dose is used in women than in men, based on preclinical data. Dose escalation in the men is independent from dose escalation in the women. Women and men receive once-daily dosing;

Part 4 includes 4 groups, 1 placebo and 3 for ASP1707, each with 9 pre-menopausal women. Subjects in each dose group receive a fixed daily dose. Subjects are domiciled for various intervals during each of 3 menstrual cycles. Dosing occurs for 21 Days during the subjects' second menstrual cycle of the study (Day 1 of Period 2); fasted or fed depending on observations from Part 2.

Being tested
ASP1707 single dose of dose levels 1 -7, Placebo single dose of dose levels 1-7, ASP1707 single dose fasted, ASP1707 single dose fed, ASP1707 multiple dose of dose levels 1-4
Keywords
Phase 1, ASP1707, Dose escalation, Food effect, Maximum tolerated dose (MTD), Healthy subjects, Single ascending dose, Multiple ascending dose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASP1707 single dose of dose levels 1 -7Drug

    Oral, dose escalation

  • Placebo single dose of dose levels 1-7Drug

    Oral, dose escalation, healthy young male

  • ASP1707 single dose fastedDrug

    Oral, healthy young male

  • ASP1707 single dose fedDrug

    Oral, healthy young male

  • ASP1707 multiple dose of dose levels 1-4Drug

    Oral, multiple dose escalation, healthy elderly male

  • Placebo multiple dose of dose levels 1-4Drug

    Oral, multiple dose escalation, healthy elderly male

  • ASP1707 multiple dose of dose levels 1-2Drug

    Oral, multiple dose escalation, healthy pre-menopausal female

  • Placebo multiple dose of dose levels 1-2Drug

    Oral, multiple dose escalation, healthy pre-menopausal female

  • ASP1707 parallel multiple dose of dose levels 1-3Drug

    Oral, multiple dose, healthy pre-menopausal female

  • Placebo parallel multiple doseDrug

    Oral, dose escalation, healthy pre-menopausal female

Study groups in NCT02368912
Study groupRoleWhat they receive
1. Single ascending dose (SAD), ASP1707 dose levels 1-7Experimentalhealthy young male
Receives: Drug: ASP1707 single dose of dose levels 1 -7
2. Single ascending dose (SAD), placebo dose levels 1-7Experimentalhealthy young male
Receives: Drug: Placebo single dose of dose levels 1-7
3. Food effect (FE), ASP1707 fastedExperimentalFasted healthy young male
Receives: Drug: ASP1707 single dose fasted
4. Food effect (FE), ASP1707 fedExperimentalFed healthy young male
Receives: Drug: ASP1707 single dose fed
5. Multiple ascending dose (MAD), ASP1707 dose levels 1-4Experimentalhealthy elderly male
Receives: Drug: ASP1707 multiple dose of dose levels 1-4
6. Multiple ascending dose (MAD), Placebo, dose levels 1-4Experimentalhealthy elderly male
Receives: Drug: Placebo multiple dose of dose levels 1-4
7. Multiple ascending dose (MAD), ASP1707, dose levels 1-2Experimentalhealthy pre-menopausal female
Receives: Drug: ASP1707 multiple dose of dose levels 1-2
8. Multiple ascending dose (MAD), Placebo dose levels 1-2Experimentalhealthy pre-menopausal female
Receives: Drug: Placebo multiple dose of dose levels 1-2
9. Parallel multiple dose, ASP1707 dose levels 1-3Experimentalhealthy pre-menopausal female
Receives: Drug: ASP1707 parallel multiple dose of dose levels 1-3
10. Parallel multiple dose, PlaceboExperimentalhealthy pre-menopausal female
Receives: Drug: Placebo parallel multiple dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety assessed by nature, frequency and severity of adverse events

    Respectively Part 1 and Part 3

    Measured: Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)

  2. Safety assessed by physical examination

    Respectively Part 1 and Part 3

    Measured: Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)

  3. Safety assessed by vital signs

    Respectively Part 1 and Part 3. Vital signs include blood pressure and pulse.

    Measured: Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)

  4. Safety assessed by safety laboratory tests

    Respectively Part 1 and Part 3, Biochemistry, hematology, and urinalysis

    Measured: Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)

  5. Safety assessed by 12 lead electrocardiogram (ECG)

    Respectively Part 1 and Part 3

    Measured: Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)

  6. Safety assessed by continuous cardiac monitoring (Holter)

    Part 3

    Measured: Days -1 and 21

  7. Pharmacokinetics (PK) of ASP1707 measured by area under the plasma concentration - time curve (AUC) extrapolated to time = infinity (AUCinf) in plasma

    Part 2

    Measured: Pre-dose (Day 1) to Day 5

  8. PK of ASP1707 measured by area under the plasma concentration-time curve (AUC) to time from the time of dosing to the last measurable concentration (AUClast) in plasma

    Part 2

    Measured: Pre-dose (Day 1) to Day 5

  9. PK of ASP1707 measured by time to reach quantifiable concentrations (tlag) in plasma

    Part 2

    Measured: Pre-dose (Day 1) to Day 5

  10. PK of ASP1707 measured by time to attain maximum concentration (tmax) in plasma

    Part 2

    Measured: Pre-dose (Day 1) to Day 5

  11. PK of ASP1707 measured by Cmax in plasma

    Part 2

    Measured: Pre-dose (Day 1) to Day 5

  12. PK of ASP1707 measured by terminal elimination half-life (t1/2) in plasma

    Part 2

    Measured: Pre-dose (Day 1) to Day 5

  13. PK of ASP1707 measured by apparent volume of distribution (Vz/F) in plasma

    Part 2

    Measured: Pre-dose (Day 1) to Day 5

  14. PK of ASP1707 measured by apparent clearance (CL/F) in plasma

    Part 2

    Measured: Pre-dose (Day 1) to Day 5

  15. PK of ASP1707 measured by amount excreted unchanged into urine (Ae) from time of dosing until last measurable concentration (Aelast) in urine

    Part 2

    Measured: Pre-dose (Day 1) to Day 5

  16. PK of ASP1707 measured by Ae extrapolated to time = infinity (Aeinf) in urine

    Part 2

    Measured: Pre-dose (Day 1) to Day 5

  17. PK of ASP1707 measured by Ae in % up to the collection time of the last measurable concentration (Aelast%) in urine

    Part 2

    Measured: Pre-dose (Day 1) to Day 5

  18. PK of ASP1707 measured by Ae in % extrapolated to time infinity (Aeinf%) in urine

    Part 2

    Measured: Pre-dose (Day 1) to Day 5

  19. PK of ASP1707 measured by renal clearance (CLR) in urine

    Part 2

    Measured: Pre-dose (Day 1) to Day 5

  20. Pharmacodynamics (PD) of ASP1707 measured by Cmax in plasma

    Part 4, period 1, 2 and 3. Estradiol (E2), Follicle-stimulating hormone (FSH) and Luteinizing Hormone (LH) levels

    Measured: Day -1 to day 15 for period 1, Day 7 to Day 15 for periods 2 and 3

  21. PD of ASP1707 measured by tmax in plasma

    Part 4, period 1, 2 and 3. E2, FSH and LH levels

    Measured: Day -1 to day 15 for period 1, Day 7 to Day 15 for periods 2 and 3

  22. PD of ASP1707 measured by average concentration (Cavg, day 7-15) in plasma

    Part 4, period 1, 2 and 3. E2, FSH and LH levels

    Measured: Pre-dose to Day 26

  23. PD of ASP1707 measured by average concentration (Cavg, day 5-19) in plasma

    Part 4, period 3. E2, FSH and LH levels

    Measured: Pre-dose to Day 26

  24. PD of ASP1707 measured by average concentration (Cavg, day 23-26) in plasma

    Part 4, period 2. E2, FSH and LH levels

    Measured: Pre-dose to Day 26

  25. PD of ASP1707 - maximal duration within therapeutic range

    Part 4, period 2. E2 levels

    Measured: Pre-dose to Day 26

  26. PD of ASP1707 - total duration within therapeutic range (20-50 pg/mL)

    Part 4, period 2. E2 levels

    Measured: Pre-dose to Day 26

  27. PD of ASP1707 - Time of onset therapeutic range

    Part 4, period 2. E2 levels

    Measured: Pre-dose to Day 26

  28. PD of ASP1707 - Time of offset therapeutic range

    Part 4, period 2. E2 levels

    Measured: Pre-dose to Day 26

  29. PD of ASP1707 - Time of start menstruation after last dose of study drug

    Part 4, period 3

    Measured: Pre-dose to Day 26

Secondary outcomes (6)

  1. PK profile of ASP1707 in plasma and urine for Part 1

    AUCinf, AUClast, tlag, tmax, Cmax, t1/2, Vz/F, CL/F, Aelast, Aeinf, Aelast%, Aeinf%, CLR

    Measured: Pre-dose (Day 1) to Day 5

  2. Safety profile assessed by nature, frequency and severity of adverse events, physical examination, vital signs, safety laboratory tests and 12 lead ECG

    Respectively Part 2 and Part 4

    Measured: Screening to End of Study Visit (ESV) (Up to 31 days and up to 62 days)

  3. PD profile of ASP1707 for Part 1 and Part 2

    Testosterone (T), LH and FSH levels: Cmin, tmin, maximal %Reduction and T only: Number and percentage of subjects with T castration level (= T < 0.5 ng/mL) after single dose, Time of onset of T < 0.5 ng/mL after single dose, Duration of T <0.5 ng/mL after single dose

    Measured: Pre-dose (Day 1) to Day 12-19

  4. PD profile of ASP1707 for Part 3

    T, LH and FSH levels: Cmin, tmin, maximal %Reduction T only: Number and percentage of subjects with T < 0.5 ng/mL at any time post-first dose, Number and percentage of subjects with T < 0.5 ng/mL after last dose, Number of subjects reaching T<0.5 ng/mL for ≥14 days, Day of onset of T < 0.5 ng/mL after multiple doses of ASP1707 (T < 0.5 ng/mL for the first time), Time of onset of T < 0.5 ng/mL after first dose, Duration of T < 0.5 ng/mL after single dose and during multiple dosing, Total duration, Maximal duration:Time from last dose to return to baseline levels for T, LH and FSH, Duration of T < 0.5 ng/mL after last dose

    Measured: Pre-dose (Day 1) to Day 39

  5. PK profile of ASP1707 in plasma and urine for Part 3

    AUCinf, AUClast, tlag, tmax, Cmax, t1/2, Vz/F, CL/F, Aelast, Aeinf, Aelast%, Aeinf%, CLR, Ctrough, AUC during the time interval between consecutive dosing (AUCtau), Accumulation Ratio (Rac), Peak Trough Ratio (PTR), Ae during the time interval between consecutive dosing (Aetau), Aetau as percentage of total dose (Aetau%), Ae during the time interval between consecutive dosing (AUCtau), (AUC0-24h), Ae0-24h, Ae0-24h%

    Measured: Pre-dose (Day 1) to Day 25

  6. PK profile of ASP1707 in plasma and urine for Part 4

    AUCtau, tmax, Cmax, t1/2, Vz/F, CL/F, CLR, Ctrough, PTR, Aetau, Aetau%,

    Measured: Pre-dose (Day 23) to Day 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2015 (estimated)
  2. Study startJun 2010
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02368912
Sponsor's protocol ID
1707-CL-0001
Other IDs
2010-018292-21
Status last verified
Feb 2015
First submitted
14 Nov 2014
Last updated
23 Feb 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP1707 single dose of dose levels 1 -7, ASP1707 single dose fasted and ASP1707 single dose fed in people with Pharmacokinetics of ASP1707 and Pharmacodynamics of ASP1707, run by Astellas Pharma Europe B.V. at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety assessed by nature, frequency and severity of adverse events (time frame: Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02368912.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.

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