HealthyPhase 1NCT03634085
Single Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of BDM-2 in Healthy Male Subjects.
A Phase 1 study testing BDM-2 in Bottle (50 mg - 3600 mg); oral suspension in people with Healthy, run by Hivih at 1 site in United Kingdom.
Trial summary
This is a first-in-human (FIH), double-blind, placebo-controlled, randomized trial in healthy adult male subjects, to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of BDM-2. The effect of food on the PK of a single dose of BDM-2 will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BDM-2 in Bottle (50 mg - 3600 mg); oral suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 May 2018to 28 Aug 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male aged between 18 and 55 years at screening, inclusive.
- Body Mass Index (BMI) 18.0-32.0 kg/m2 at screening, inclusive.
- Good physical and mental health as established by medical history, physical examination, respiratory rate, electrocardiogram (ECG) and vital signs (including body temperature) recording, and results of biochemistry, coagulation, hematology and urinalysis tests during screening as judged by the investigator.
- Non-smoker/non-user of nicotine containing products for at least 3 months prior to screening, to be confirmed by a urine cotinine dipstick test at screening and on Day -1 of the first session.
- Availability and willingness to complete the trial and follow the instructions of the investigator or trial-site personnel.
- Willing and able to adhere to the prohibitions and restrictions specified in the protocol
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- Easy venous accessibility.
- Must have signed an Informed Consent Form (ICF) prior to screening, indicating that he understands the purpose of, and procedures required for the trial, and is willing to participate in the trial.
- Must agree to provide a blood sample for DNA research.
- Subject who is heterosexually active with a woman of childbearing potential must agree to use 2 effective methods of birth control (i.e., male condom with either female intrauterine device, diaphragm, cervical cap or hormone-based contraceptive), during the trial and for at least 90 days after receiving the last dose of trial medication. If the female sexual partner is postmenopausal for at least 2 years, or is surgically sterile (has had a total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise is incapable of becoming pregnant, the birth control methods mentioned are not applicable, however, subjects should use a condom during the trial and for at least 90 days after receiving the last dose of trial medication to prevent unintended exposure via the ejaculate.
- Subjects who had vasectomy and have a female partner of childbearing potential must use a male condom during the trial and for at least 90 days after receiving the last dose of trial medication.
- Note: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction.
- Note: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial medication (during the trial and for at least 90 days after receiving the last dose of trial medication). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the trial and the preferred and usual lifestyle of the subject.
- Note: Subjects will be instructed that if their partner becomes pregnant during the trial this should be reported to the investigator. The investigator should also be notified of pregnancy occurring during the trial but confirmed after completion of the trial. In the event that a subject's partner is subsequently found to be pregnant after the subject is included in the trial, then consent will be sought from the partner and, if granted, any pregnancy will be followed and the status of mother and/or child will be reported to the sponsor after delivery.
- Must agree not to donate sperm during the trial and for at least 90 days after receiving the last dose of trial medication.
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrinologic, genitourinary, renal, hepatic, respiratory, inflammatory, neoplastic, or infectious disease, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the trial results.
- Clinically significant abnormalities of hematology or biochemistry (out of range values should be considered as to their significance and the subject not included if the value is considered to be detrimental). This includes but is not limited to liver function tests.
- Subjects with Gilbert's syndrome.
- Clinically significant presence or history of allergy or intolerance (including lactose), or presence or history of clinically significant allergy requiring treatment, as judged by the investigator (hay fever is allowed unless it is active).
- Positive serology for hepatitis A virus (HAV) immunoglobulin M (IgM), hepatitis B virus surface antigen (HBsAg), anti-hepatitis C virus antibodies (anti-HCV-AB), or anti HIV antibodies 1+2 (anti-HIV-AB 1+2) at screening.
- History of alcohol or drug abuse within the last 2 years before screening or positive test result(s) for alcohol and/or drugs of abuse at screening or on Day -1 of first session.
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- Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
- Surgery of gastro-intestinal tract that might interfere with absorption (subjects who have had cholecystectomy may be included). Subject has currently significant and active diarrhea, nausea, or constipation that in the investigator's opinion could influence drug absorption or bioavailability.
- Intake of any disallowed therapies before the first dose of trial medication (on Day 1 of the first session).
- Donation of blood or blood products or substantial loss of blood (more than 500 mL) within 3 months before first dose of trial medication (on Day 1 of the first session) or the intention to donate blood or blood products during the trial
- Major surgery, fracture, or prolonged immobilization (more than 2 weeks) within 3 months preceding screening, or surgery has been planned during the time the subject is expected to participate in the trial.
- Unable to swallow solid, oral dosage forms (multiple capsules) whole with the aid of water (subjects may not chew, divide, dissolve, or crush the trial medication).
- Plans to father a child while enrolled in the trial or within 90 days after receiving the last dose of trial medication.
- History of hypersensitivity or idiosyncrasy to any of the components of the investigational drug.
- Participation in a clinical trial within 3 months before first dose of trial medication (on Day 1 of the first session).
- Participation in a trial of an investigational product or an experimental medical device within 3 months or within a period less than 5 times the drug's half-life, whichever is longer, prior to the first dose (on Day 1 of the first session) or during this trial.
- Trial site employee or immediate family members of a trial site or sponsor employee.
- Have previously been enrolled in this trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences
Ruddington, Nottingham, NG11 6JS
About this study
Official title: A Single Ascending Dose Trial Investigating the Safety, Tolerability and Pharmacokinetics of Orally Administered BDM-2 in Healthy Male Subjects
This is a first-in-human (FIH), double-blind, placebo-controlled, randomized trial in healthy adult male subjects, to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of BDM-2. The effect of food on the PK of a single dose of BDM-2 will also be evaluated.
Read the detailed description
The Sponsor HIVIH is developing a new antiretroviral medicine, BDM-2, for the potential treatment of Human Immunodeficiency Virus (HIV). The study will investigate the safety, tolerability and pharmacokinetics (PK) (how well the medicine is taken up by the body) of single doses of the test medicine given by mouth, in healthy male volunteers. The effect of food on the PK of the test medicine will also be assessed.
This is the first time the medicine will be dosed in humans. Over 6 study periods, ascending (increasing) doses of the test medicine or placebo (dummy drug) will be given to 16 healthy male volunteers in the fasted state. Alternately dosed to two groups each made up of 8 volunteers. After each dose volunteers will remain in the clinical unit for 48 hours for blood samples to be taken and safety assessments to be performed.
To investigate the effect of food, it is planned that in Period 7 the medicine will be administered in the fed state. On the 7th study period one of the doses administered in a previous period will be administered under fed conditions (with food). Each volunteer will receive 3 or 4 single doses of test medicine or placebo.
- Conditions
- Healthy
- Being tested
- BDM-2 in Bottle (50 mg - 3600 mg); oral suspension
- Keywords
- safety, tolerability, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspensionDrug
BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used. Receives: Drug: BDM-2 in Bottle (50 mg - 3600 mg); oral suspension |
| Cohort B | Experimental | Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo. Receives: Drug: BDM-2 in Bottle (50 mg - 3600 mg); oral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Related Adverse Event, Including Abnormal Laboratory Events
All AEs, including clinical laboratory, vitals signs, body temperature, respiratory rate, physical examinations and ECGs will be analyzed in all subjects receiving BDM-2.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start17 May 2018
- Primary completion13 Aug 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Parallel groups
- Model description
- In Sessions I to VI, 6 single, orally administered ascending doses of BDM-2 or placebo will be investigated, alternately dosed in 2 cohorts of 8 healthy male subjects each (Cohorts A and B). For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo. In Sessions I to VI, doses are planned to be administered under fasted conditions.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hivih
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Venn Life Sciences
- Responsible party
- Sponsor
- Investigators
- Sharan Sidhu, MB ChB, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634085
- Sponsor's protocol ID
- BDM-2-C001
- Status last verified
- Jun 2020
- First submitted
- 2 Aug 2018
- Last updated
- 17 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bonnard D, Le Rouzic E, Singer MR, Yu Z, Le Strat F, Batisse C, Batisse J, Amadori C, Chasset S, Pye VE, Emiliani S, Ledoussal B, Ruff M, Moreau F, Cherepanov P, Benarous R. Biological and Structural Analyses of New Potent Allosteric Inhibitors of HIV-1 Integrase. Antimicrob Agents Chemother. 2023 Jul 18;67(7):e0046223. doi: 10.1128/aac.00462-23. Epub 2023 Jun 13.
PubMed 37310224
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Ascending Dose Trial Investigating the Safety, Tolerability and Pharmacokinetics of Orally Administered BDM-2 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03634085
- Acronym / sponsor ID
- BDM-2-C001
- Conditions
- Healthy
- Keywords
- safety, tolerability, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- HivihIndustry (pharma, biotech, devices)
- Collaborators
- Venn Life Sciences
- Study start
- 17 May 2018 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Posted 17 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human (FIH), double-blind, placebo-controlled, randomized trial in healthy adult male subjects, to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of BDM-2. The effect of food on the PK of a single dose of BDM-2 will also be evaluated.
Detailed description
The Sponsor HIVIH is developing a new antiretroviral medicine, BDM-2, for the potential treatment of Human Immunodeficiency Virus (HIV). The study will investigate the safety, tolerability and pharmacokinetics (PK) (how well the medicine is taken up by the body) of single doses of the test medicine given by mouth, in healthy male volunteers. The effect of food on the PK of the test medicine will also be assessed.
This is the first time the medicine will be dosed in humans. Over 6 study periods, ascending (increasing) doses of the test medicine or placebo (dummy drug) will be given to 16 healthy male volunteers in the fasted state. Alternately dosed to two groups each made up of 8 volunteers. After each dose volunteers will remain in the clinical unit for 48 hours for blood samples to be taken and safety assessments to be performed.
To investigate the effect of food, it is planned that in Period 7 the medicine will be administered in the fed state. On the 7th study period one of the doses administered in a previous period will be administered under fed conditions (with food). Each volunteer will receive 3 or 4 single doses of test medicine or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- In Sessions I to VI, 6 single, orally administered ascending doses of BDM-2 or placebo will be investigated, alternately dosed in 2 cohorts of 8 healthy male subjects each (Cohorts A and B). For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo. In Sessions I to VI, doses are planned to be administered under fasted conditions.
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: BDM-2 in Bottle (50 mg - 3600 mg); oral suspensionAscending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo. The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used. |
| Cohort B | Experimental | Drug: BDM-2 in Bottle (50 mg - 3600 mg); oral suspensionAscending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Healthy male aged between 18 and 55 years at screening, inclusive.
- Body Mass Index (BMI) 18.0-32.0 kg/m2 at screening, inclusive.
- Good physical and mental health as established by medical history, physical examination, respiratory rate, electrocardiogram (ECG) and vital signs (including body temperature) recording, and results of biochemistry, coagulation, hematology and urinalysis tests during screening as judged by the investigator.
- Non-smoker/non-user of nicotine containing products for at least 3 months prior to screening, to be confirmed by a urine cotinine dipstick test at screening and on Day -1 of the first session.
- Availability and willingness to complete the trial and follow the instructions of the investigator or trial-site personnel.
Key exclusion criteria (18 listed)
- History of or current clinically significant medical illness including (but not limited to) gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrinologic, genitourinary, renal, hepatic, respiratory, inflammatory, neoplastic, or infectious disease, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the trial results.
- Clinically significant abnormalities of hematology or biochemistry (out of range values should be considered as to their significance and the subject not included if the value is considered to be detrimental). This includes but is not limited to liver function tests.
- Subjects with Gilbert's syndrome.
- Clinically significant presence or history of allergy or intolerance (including lactose), or presence or history of clinically significant allergy requiring treatment, as judged by the investigator (hay fever is allowed unless it is active).
- Positive serology for hepatitis A virus (HAV) immunoglobulin M (IgM), hepatitis B virus surface antigen (HBsAg), anti-hepatitis C virus antibodies (anti-HCV-AB), or anti HIV antibodies 1+2 (anti-HIV-AB 1+2) at screening.
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 |
|---|---|---|
| BDM-2 in Bottle (50 mg - 3600 mg); oral suspensionBDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration. | Drug | Cohort A, Cohort B |
Primary outcome
Number of Treatment Related Adverse Event, Including Abnormal Laboratory Events
Time frame: up to 4 months
All AEs, including clinical laboratory, vitals signs, body temperature, respiratory rate, physical examinations and ECGs will be analyzed in all subjects receiving BDM-2.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37310224Bonnard D, Le Rouzic E, Singer MR, Yu Z, Le Strat F, Batisse C, Batisse J, Amadori C, Chasset S, Pye VE, Emiliani S, Ledoussal B, Ruff M, Moreau F, Cherepanov P, Benarous R. Biological and Structural Analyses of New Potent Allosteric Inhibitors of HIV-1 Integrase. Antimicrob Agents Chemother. 2023 Jul 18;67(7):e0046223. doi: 10.1128/aac.00462-23. Epub 2023 Jun 13.
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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.
Sharan Sidhu, MB ChB principal investigator
Quotient 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 BDM-2 in Bottle (50 mg - 3600 mg); oral suspension in people with Healthy, run by Hivih at 1 site in United Kingdom.
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 15 inclusion and 18 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 17 Jun 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 17 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Treatment Related Adverse Event, Including Abnormal Laboratory Events (time frame: up to 4 months). 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 NCT03634085, which also lists 1 linked publication.
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 17 Jun 2020.