Healthy SubjectsPhase 1NCT03879928
A SAD, MAD, and FE Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of FM101 in Healthy Volunteers
A Phase 1 study testing Single ascending doses of FM101, Multiple ascending doses of FM101 and Food effects of FM101 in people with Healthy Subjects, run by Future Medicine at 1 site in Netherlands.
Trial summary
This a double blind, randomized, placebo controlled, single and multiple ascending dose (SAD/MAD) study in healthy subjects. Safety evaluation will include adverse events (TEAEs), clinical laboratory values, vital signs, ECGs, and physical examinations. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Single ascending doses of FM101, Multiple ascending doses of FM101 and Food effects of FM101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Jan 2019to 1 May 2020
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gender: male or female
- Age: 18 - 50 years, inclusive, at screening
- Body mass index (BMI) : 18.0 - 32.0 kg/m2 (inclusive)
- Weight : ≥ 50 kg
- Status : healthy subjects
- At screening, females must be non-pregnant and non-lactating, or of non child-bearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year post menopausal [amenorrhea duration of 12 consecutive months); non-pregnancy will be confirmed for all females by a serum pregnancy test conducted at screening, and a urine pregnancy test at each admission and at follow-up.
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- Female subjects of child-bearing potential, with a fertile male sexual partner, must agree to use adequate contraception from screening until 90 days after the follow up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable.
- Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject is acceptable.
- All prescribed medication must have been stopped at least 14 days prior to (each) admission to the clinical research center. An exception is made for hormonal contraceptives, which may be used throughout the study.
- All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 7 days prior to (each) admission to the clinical research center. An exception is made for paracetamol, which is allowed up to admission to the clinical research center.
- Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), grapefruit (juice), and tobacco products from 48 hours prior to (each) admission to the clinical research center.
- Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
- Willing and able to sign the ICF.
Who cannot join
- Employee of CRO or the Sponsor.
- History of relevant drug and/or food allergies.
- Using tobacco products within 60 days prior to (the first) drug administration.
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
- Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, gamma hydroxybutyric acid [GHB], tricyclic antidepressants, and alcohol) at screening and (each) admission to the clinical research center.
- Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
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- Positive screen for hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV) antibodies, or anti human immunodeficiency virus (HIV) 1 and 2 antibodies.
- Participation in a drug study within 60 days prior to (the first) drug administration in the current study. Participation in more than 3 other drug studies (for male subjects) / more than 2 other drug studies (for female subjects) in the 10 months prior to (the first) drug administration in the current study.
- Donation or loss of more than 100 mL of blood within 60 days prior to (the first) drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to (the first) drug administration in the current study.
- Significant and/or acute illness within 5 days prior to (the first) drug administration that may impact safety assessments, in the opinion of the Investigator.
- Non-willingness to consume the high-fat breakfast (Part B only).
- Unsuitable veins for infusion or blood sampling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Alternating Panel Single Ascending Dose, Sequential Multiple Ascending Dose, and Food Effect Study of FM101 in Healthy Male and Female Volunteers
This a double blind, randomized, placebo controlled, single and multiple ascending dose (SAD/MAD) study in healthy subjects. Safety evaluation will include adverse events (TEAEs), clinical laboratory values, vital signs, ECGs, and physical examinations.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study in healthy volunteers designed to assess the safety, tolerability and PK of FM101. This study will consist of 3 parts: a SAD part, a single dose FE part and a MAD part. Each subject is to participate in only 1 part of the study.
- Conditions
- Healthy Subjects
- Being tested
- Single ascending doses of FM101, Multiple ascending doses of FM101, Food effects of FM101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single ascending doses of FM101Drug
The study drug (FM101 and placebo comparator) will be administered orally as SAD doses
Multiple ascending doses of FM101Drug
The study drug (FM101 and placebo comparator) will be administered orally as MAD doses
Food effects of FM101Drug
The study drug (FM101) will be administered orally under fasted condition and fed condition.
| Study group | Role | What they receive |
|---|---|---|
| Placebo for SAD | Placebo comparator | Placebo comparator for SAD Receives: Drug: Single ascending doses of FM101 |
| FM101 75 mg for SAD | Experimental | Single ascending doses of FM101 Receives: Drug: Single ascending doses of FM101 |
| FM101 150 mg for SAD | Experimental | Single ascending doses of FM101 Receives: Drug: Single ascending doses of FM101 |
| FM101 300 mg for SAD | Experimental | Single ascending doses of FM101 Receives: Drug: Single ascending doses of FM101 |
| FM101 600 mg for SAD | Experimental | Single ascending doses of FM101 Receives: Drug: Single ascending doses of FM101 |
| FM101 1200 mg for SAD | Experimental | Single ascending doses of FM101 Receives: Drug: Single ascending doses of FM101 |
| FM101 2400 mg for SAD | Experimental | Single ascending doses of FM101 Receives: Drug: Single ascending doses of FM101 |
| Placebo for MAD | Placebo comparator | Placebo comparator for MAD Receives: Drug: Multiple ascending doses of FM101 |
| FM101 150 mg (QD) for MAD | Experimental | Multiple ascending doses of FM101 Receives: Drug: Multiple ascending doses of FM101 |
| FM101 450 mg (QD) for MAD | Experimental | Multiple ascending doses of FM101 Receives: Drug: Multiple ascending doses of FM101 |
| FM101 600 mg (BID) for MAD | Experimental | Multiple ascending doses of FM101 Receives: Drug: Multiple ascending doses of FM101 |
| FM101 300 mg under fasted condition for FE | Experimental | Food Effect of FM101 Receives: Drug: Food effects of FM101 |
| FM101 300 mg under fed condition for FE | Experimental | Food Effect of FM101 Receives: Drug: Food effects of FM101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of FM101 after SAD and MAD doses to healthy volunteers by assessing the number, severity, and type of TEAEs.
The number of TEAEs (frequency of occurrence, number of subjects experiencing the event)
Measured: SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
To evaluate the change in clinical laboratory values from the baseline after SAD and MAD doses.
The number of abnormalities with clinical significance (frequency of occurrence, number of subjects experiencing the event)
Measured: SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
To evaluate the change in vital signs from the baseline after SAD and MAD doses.
The number of abnormalities with clinical significance (frequency of occurrence, number of subjects experiencing the event)
Measured: SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
To evaluate the change in electrocardiograms (ECGs) after SAD and MAD doses.
The number of abnormalities with clinical significance (frequency of occurrence, number of subjects experiencing the event).
Measured: SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
To evaluate the change in physical examinations after SAD and MAD doses.
The number of abnormalities with clinical significance (frequency of occurrence, number of subjects experiencing the event).
Measured: SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
To assess maximum observed plasma concentration (Cmax) following SAD and MAD doses
Cmax of FM101 in plasma will be calculated as applicable:
SAD phase - cohort 1 to 6 , MAD phase - cohort 2
Measured: SAD phase - Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, and 72 hours. MAD phase - Day 1 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after the first dose. Day 3 to Day 7 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours.
To assess area under plasma concentration-time curve from hour 0 to last sample following SAD and MAD doses
AUClast of FM101 in plasma will be calculated as applicable:
SAD phase - cohort 1 to 6 , MAD phase - cohort 2
Measured: SAD phase - Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, and 72 hours. MAD phase - Day 1 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after the first dose. Day 3 to Day 7 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours.
To assess area under plasma concentration-time curve from hour 0 to infinity following SAD and MAD doses
AUCinf of FM101 in plasma will be calculated as applicable:
SAD phase - cohort 1 to 6 , MAD phase - cohort 2
Measured: SAD phase - Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, and 72 hours. MAD phase - Day 1 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after the first dose. Day 3 to Day 7 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours.
To assess time to reach the maximum concentration in plasma (Tmax) following SAD and MAD doses
Tmax of FM101 in plasma will be calculated as applicable:
SAD phase - cohort 1 to 6 , MAD phase - cohort 2
Measured: SAD phase - Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, and 72 hours. MAD phase - Day 1 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after the first dose. Day 3 to Day 7 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours.
To assess terminal elimination rate constant (Kel) following SAD and MAD doses
Kel of FM101 in plasma will be calculated as applicable:
SAD phase - cohort 1 to 6 , MAD phase - cohort 2
Measured: SAD phase - Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, and 72 hours. MAD phase - Day 1 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after the first dose. Day 3 to Day 7 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours.
To assess terminal half-life (t1/2) following SAD and MAD doses
t1/2 of FM101 in plasma will be calculated as applicable: SAD phase - cohort 1 to 6 , MAD phase - cohort 2
Measured: SAD phase - Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, and 72 hours. MAD phase - Day 1 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after the first dose. Day 3 to Day 7 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours.
Secondary outcomes (6)
To evaluate the effect of food on the plasma Cmax of FM101 after a single dose
Cmax of FM101 under fasted and fed conditions will be calculated after a single dose.
Measured: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours post-dose.
To evaluate the effect of food on the plasma AUClast of FM101 after a single dose
AUClast of FM101 under fasted and fed conditions will be calculated after a single dose.
Measured: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours post-dose.
To evaluate the effect of food on the plasma AUCinf of FM101 after a single dose
AUCinf of FM101 under fasted and fed conditions will be calculated after a single dose.
Measured: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours post-dose.
To evaluate the effect of food on the plasma Tmax of FM101 after a single dose
Tmax of FM101 under fasted and fed conditions will be calculated after a single dose.
Measured: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours post-dose.
To evaluate the effect of food on the plasma Kel of FM101 after a single dose
Kel of FM101 under fasted and fed conditions will be calculated after a single dose.
Measured: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours post-dose.
To evaluate the effect of food on the plasma t1/2 of FM101 after a single dose
t1/2 of FM101 under fasted and fed conditions will be calculated after a single dose.
Measured: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start8 Jan 2019
- Primary completion18 Aug 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- WanSeok Jeong, MBA, Study chair, Future Medicine Ltd.Renger Tiessen, PhD, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879928
- Sponsor's protocol ID
- FM101-CTP1-001
- Status last verified
- Sep 2020
- First submitted
- 12 Mar 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Alternating Panel Single Ascending Dose, Sequential Multiple Ascending Dose, and Food Effect Study of FM101 in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT03879928
- Acronym / sponsor ID
- FM101-CTP1-001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Future MedicineIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 18 Aug 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This a double blind, randomized, placebo controlled, single and multiple ascending dose (SAD/MAD) study in healthy subjects. Safety evaluation will include adverse events (TEAEs), clinical laboratory values, vital signs, ECGs, and physical examinations.
Detailed description
This is a randomized, double-blind, placebo-controlled study in healthy volunteers designed to assess the safety, tolerability and PK of FM101. This study will consist of 3 parts: a SAD part, a single dose FE part and a MAD part. Each subject is to participate in only 1 part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Placebo for SAD | Placebo comparator | Drug: Single ascending doses of FM101Placebo comparator for SAD |
| FM101 75 mg for SAD | Experimental | Drug: Single ascending doses of FM101Single ascending doses of FM101 |
| FM101 150 mg for SAD | Experimental | Drug: Single ascending doses of FM101Single ascending doses of FM101 |
| FM101 300 mg for SAD | Experimental | Drug: Single ascending doses of FM101Single ascending doses of FM101 |
| FM101 600 mg for SAD | Experimental | Drug: Single ascending doses of FM101Single ascending doses of FM101 |
| FM101 1200 mg for SAD | Experimental | Drug: Single ascending doses of FM101Single ascending doses of FM101 |
| FM101 2400 mg for SAD | Experimental | Drug: Single ascending doses of FM101Single ascending doses of FM101 |
| Placebo for MAD | Placebo comparator | Drug: Multiple ascending doses of FM101Placebo comparator for MAD |
| FM101 150 mg (QD) for MAD | Experimental | Drug: Multiple ascending doses of FM101Multiple ascending doses of FM101 |
| FM101 450 mg (QD) for MAD | Experimental | Drug: Multiple ascending doses of FM101Multiple ascending doses of FM101 |
| FM101 600 mg (BID) for MAD | Experimental | Drug: Multiple ascending doses of FM101Multiple ascending doses of FM101 |
| FM101 300 mg under fasted condition for FE | Experimental | Drug: Food effects of FM101Food Effect of FM101 |
| FM101 300 mg under fed condition for FE | Experimental | Drug: Food effects of FM101Food Effect of FM101 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Gender: male or female
- Age: 18 - 50 years, inclusive, at screening
- Body mass index (BMI) : 18.0 - 32.0 kg/m2 (inclusive)
- Weight : ≥ 50 kg
- Status : healthy subjects
Key exclusion criteria (12 listed)
- Employee of CRO or the Sponsor.
- History of relevant drug and/or food allergies.
- Using tobacco products within 60 days prior to (the first) drug administration.
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
- Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, gamma hydroxybutyric acid [GHB], tricyclic antidepressants, and alcohol) at screening and (each) admission to the clinical research center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single ascending doses of FM101The study drug (FM101 and placebo comparator) will be administered orally as SAD doses | Drug | FM101 1200 mg for SAD, FM101 150 mg for SAD, FM101 2400 mg for SAD, FM101 300 mg for SAD, FM101 600 mg for SAD, FM101 75 mg for SAD, Placebo for SAD |
| Multiple ascending doses of FM101The study drug (FM101 and placebo comparator) will be administered orally as MAD doses | Drug | FM101 150 mg (QD) for MAD, FM101 450 mg (QD) for MAD, FM101 600 mg (BID) for MAD, Placebo for MAD |
| Food effects of FM101The study drug (FM101) will be administered orally under fasted condition and fed condition. | Drug | FM101 300 mg under fasted condition for FE, FM101 300 mg under fed condition for FE |
Primary outcome
To evaluate the safety and tolerability of FM101 after SAD and MAD doses to healthy volunteers by assessing the number, severity, and type of TEAEs.
Time frame: SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
The number of TEAEs (frequency of occurrence, number of subjects experiencing the event)
To evaluate the change in clinical laboratory values from the baseline after SAD and MAD doses.
Time frame: SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
The number of abnormalities with clinical significance (frequency of occurrence, number of subjects experiencing the event)
To evaluate the change in vital signs from the baseline after SAD and MAD doses.
Time frame: SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
The number of abnormalities with clinical significance (frequency of occurrence, number of subjects experiencing the event)
To evaluate the change in electrocardiograms (ECGs) after SAD and MAD doses.
Time frame: SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
The number of abnormalities with clinical significance (frequency of occurrence, number of subjects experiencing the event).
To evaluate the change in physical examinations after SAD and MAD doses.
Time frame: SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
The number of abnormalities with clinical significance (frequency of occurrence, number of subjects experiencing the event).
To assess maximum observed plasma concentration (Cmax) following SAD and MAD doses
Time frame: SAD phase - Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, and 72 hours. MAD phase - Day 1 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after the first dose. Day 3 to Day 7 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours.
Cmax of FM101 in plasma will be calculated as applicable: SAD phase - cohort 1 to 6 , MAD phase - cohort 2
To assess area under plasma concentration-time curve from hour 0 to last sample following SAD and MAD doses
Time frame: SAD phase - Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, and 72 hours. MAD phase - Day 1 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after the first dose. Day 3 to Day 7 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours.
AUClast of FM101 in plasma will be calculated as applicable: SAD phase - cohort 1 to 6 , MAD phase - cohort 2
To assess area under plasma concentration-time curve from hour 0 to infinity following SAD and MAD doses
Time frame: SAD phase - Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, and 72 hours. MAD phase - Day 1 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after the first dose. Day 3 to Day 7 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours.
AUCinf of FM101 in plasma will be calculated as applicable: SAD phase - cohort 1 to 6 , MAD phase - cohort 2
To assess time to reach the maximum concentration in plasma (Tmax) following SAD and MAD doses
Time frame: SAD phase - Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, and 72 hours. MAD phase - Day 1 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after the first dose. Day 3 to Day 7 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours.
Tmax of FM101 in plasma will be calculated as applicable: SAD phase - cohort 1 to 6 , MAD phase - cohort 2
To assess terminal elimination rate constant (Kel) following SAD and MAD doses
Time frame: SAD phase - Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, and 72 hours. MAD phase - Day 1 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after the first dose. Day 3 to Day 7 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours.
Kel of FM101 in plasma will be calculated as applicable: SAD phase - cohort 1 to 6 , MAD phase - cohort 2
To assess terminal half-life (t1/2) following SAD and MAD doses
Time frame: SAD phase - Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, and 72 hours. MAD phase - Day 1 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after the first dose. Day 3 to Day 7 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours.
t1/2 of FM101 in plasma will be calculated as applicable: SAD phase - cohort 1 to 6 , MAD phase - cohort 2
6 secondary outcomes
To evaluate the effect of food on the plasma Cmax of FM101 after a single dose
Time frame: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours post-dose.
To evaluate the effect of food on the plasma AUClast of FM101 after a single dose
Time frame: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours post-dose.
To evaluate the effect of food on the plasma AUCinf of FM101 after a single dose
Time frame: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours post-dose.
To evaluate the effect of food on the plasma Tmax of FM101 after a single dose
Time frame: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours post-dose.
To evaluate the effect of food on the plasma Kel of FM101 after a single dose
Time frame: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours post-dose.
To evaluate the effect of food on the plasma t1/2 of FM101 after a single dose
Time frame: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WanSeok Jeong, MBA study chair
Future Medicine Ltd.
Renger Tiessen, PhD principal investigator
PRA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single ascending doses of FM101, Multiple ascending doses of FM101 and Food effects of FM101 in people with Healthy Subjects, run by Future Medicine at 1 site in Netherlands.
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 13 inclusion and 12 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 9 Sep 2020. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
To evaluate the safety and tolerability of FM101 after SAD and MAD doses to healthy volunteers by assessing the number, severity, and type of TEAEs. (time frame: SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2020.